TG THERAPEUTICS, INC. - Annual Report: 2007 (Form 10-K)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
x |
Annual
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934 for the fiscal year ended December 31,
2007
|
o |
Transition
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934 for the transition period from
___to___
|
Commission
File Number 1-32639
MANHATTAN
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or other jurisdiction of incorporation or organization)
|
36-3898269
(I.R.S.
Employer Identification No.)
|
810
Seventh Avenue, 4th
Floor, New York, New York
(Address
of Principal Executive Offices)
|
10019
(Zip
Code)
|
(212)
582-3950
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
|
Name
of each exchange on which registered
|
Common
Stock, $0.001 par value
|
OTC
Bulletin Board
|
Securities
registered pursuant to Section 12(g) of the Exchange Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act. o Yes x
No
Indicate
by check mark if the registrant is not required to file reports pursuant
to
Section 13 or 15(d) of the Exchange Act. o Yes x
No
Indicate
by check mark whether the registrant (1) filed all reports required to be
filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. x
Yes o No
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form
10-K
or any amendment to this Form 10-K. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o (Do not check if
a smaller reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act). o
Yes x No
The
aggregate market value of the voting and non-voting common equity of the
registrant held by non-affiliates of the registrant on March 17, 2008 based
on
the closing price of the common stock as reported on the American Stock Exchange
on such date was $7,206,064.
As
of
March17, 2008 there were 70,624,232 outstanding shares of common stock, par
value $.001 per share.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the registrant’s definitive Proxy Statement for its Annual Meeting of
Stockholders to be held on June 25, 2008 (the “2008 Proxy Statement”) are
incorporated by reference into Part III of this Form 10-K, to the extent
described in Part III. The 2008 Proxy Statement will be filed within 120
days
after the fiscal year ended December 31, 2007.
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
TABLE
OF CONTENTS
Page
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PART
I
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Item
1
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Business
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2
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Item
1A
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Risk
Factors
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17
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Item
2
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Legal
Proceedings
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27
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Item
3
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Properties
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27
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Item
4
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Submission
of Matters to a Vote of Security Holders
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27
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PART
II
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||
Item
5
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Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
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28
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Item
6
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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29
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Item
7
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Financial
Statements and Supplementary Data
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45
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Item
8
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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45
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Item
8A(T)
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Controls
and Procedures
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45
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Item
8B
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Other
Information
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46
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PART
III
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||
Item
9
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Directors,
Executive Officers and Corporate Governance
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46
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Item
10
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Executive
Compensation
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47
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Item
11
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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47
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Item
12
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Certain
Relationships and Related Transactions, and Director
Independence
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47
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PART
IV
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||
Item
13
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Exhibits,
Financial Statement Schedules
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48
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Item
14
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Principal
Accounting Fees and Services
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51
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Index
to Consolidated Financial Statements
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F-1
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References
to the “Company,” the “Registrant,” “we,” “us,” or “our” or in this Annual
Report on Form 10-K refer to Manhattan Pharmaceuticals, Inc., a Delaware
corporation, and our consolidated subsidiaries, together taken as a whole,
unless the context indicates otherwise.
Forward-Looking
Statements
This
annual report on Form 10-K contains forward-looking statements within the
meaning of Section27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section21E of the Exchange Act. Any statements about
our
expectations, beliefs, plans, objectives, assumptions or future events or
performance are not historical facts and may be forward-looking. These
statements are often, but not always, made through the use of words or phrases
such as “anticipate,” “estimate,” “plan,” “project,” “expect,” “may,” “intend”
and similar words or phrases. Accordingly, these statements involve estimates,
assumptions and uncertainties that could cause actual results to differ
materially from those expressed in them. These statements are therefore subject
to risks and uncertainties, known and unknown, which could cause actual results
and developments to differ materially from those expressed or implied in
such
statements. Such risks and uncertainties relate to, among other factors:
·
|
the
development of our drug candidates;
|
·
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the
regulatory approval of our drug candidates;
|
·
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our
use of clinical research centers and other contractors;
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·
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our
ability to find collaborative partners for research, development
and
commercialization of potential
products;
|
·
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acceptance
of our products by doctors, patients or payers;
|
·
|
our
ability to market any of our products;
|
·
|
our
history of operating losses;
|
·
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our
ability to compete against other companies and research institutions;
|
·
|
our
ability to secure adequate protection for our intellectual property;
|
·
|
our
ability to attract and retain key personnel;
|
·
|
availability
of reimbursement for our product candidates;
|
·
|
the
effect of potential strategic transactions on our business;
|
·
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our
ability to obtain adequate financing; and
|
·
|
the
volatility of our stock price.
|
Further,
any forward-looking statement speaks only as of the date on which it is made,
and we undertake no obligation to update any forward-looking statement or
statements to reflect events or circumstances after the date on which such
statement is made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time, and it is not possible for us to predict
which
factors will arise. In addition, we cannot assess the impact of each factor
on
our business or the extent to which any factor, or combination of factors,
may
cause actual results to differ materially from those contained in any
forward-looking statements.
1
PART
I
ITEM
1. DESCRIPTION OF BUSINESS
Overview
We
are a
clinical stage specialty pharmaceutical company focused on developing and
commercializing innovative pharmaceutical therapies for underserved patient
populations. We aim to acquire rights to these technologies by licensing
or
otherwise acquiring an ownership interest, funding their research and
development and eventually either bringing the technologies to market or
out-licensing. We currently have four product candidates in development:
Hedrin™, a novel, non-insecticide treatment for pediculosis (head lice); Topical
PTH (1-34) for the treatment of psoriasis; Altoderm™ (topical cromolyn sodium)
for the treatment of pruritus associated with dermatologic conditions including
atopic dermatitis; and Altolyn™ (oral tablet cromolyn sodium) for the treatment
of mastocytosis. We have not received regulatory approval for, or generated
commercial revenues from marketing or selling any drugs.
Our
executive offices are located at 810 Seventh Avenue, 4th
floor,
New York, NY 10019 USA. Our telephone number is (212) 582-3950 and our internet
website address is www.manhattanpharma.com.
Corporate
History – Merger Transaction(s)
We
were
incorporated in Delaware in 1993 under the name “Atlantic Pharmaceuticals, Inc.”
and, in March 2000, we changed our name to “Atlantic Technology Ventures, Inc.”
In 2003, we completed a “reverse acquisition” of privately held “Manhattan
Research Development, Inc.” In connection with this transaction, we also changed
our name to “Manhattan Pharmaceuticals, Inc.” From an accounting perspective,
the accounting acquirer is considered to be Manhattan Research Development,
Inc.
and accordingly, the historical financial statements are those of Manhattan
Research Development, Inc.
During
2005 we merged with Tarpan Therapeutics, Inc. (“Tarpan”). Tarpan was a privately
held New York based biopharmaceutical company developing dermatological
therapeutics. Through the merger, we acquired Tarpan’s primary product
candidate, Topical PTH (1-34) for the treatment of psoriasis. In consideration
for their shares of Tarpan’s capital stock, the stockholders of Tarpan received
an aggregate of approximately 10,731,000 shares of our common stock,
representing approximately 20% of our then outstanding common shares. This
transaction was accounted for as a purchase of Tarpan by the
Company.
Our
Research and Development Programs
Hedrin™
In
June
2007, Manhattan Pharmaceuticals entered into an exclusive license agreement
with
Thornton & Ross Ltd. (“T&R”) and Kerris, S.A. (“Kerris”) for a product
candidate called Hedrin (the “Hedrin License Agreement”). We acquired an
exclusive North American license to certain patent rights and other intellectual
property relating to Hedrin, a non-insecticide product candidate for the
treatment of head lice. In addition, and at the same time, we also entered
into
a Supply Agreement with T&R pursuant to which T&R will be the Company’s
exclusive supplier of Hedrin product (the “Hedrin Supply
Agreement”).
2
In
February 2008, Manhattan Pharmaceuticals announced that it had entered into
a
joint venture agreement with Nordic Biotech Advisors ApS (“Nordic”) to develop
and commercialize Hedrin. A 50/50 joint venture entity was formed that now
owns,
will develop and will secure a commercialization partner for the Hedrin product
in North America (the “Hedrin JV”). Manhattan Pharmaceuticals will manage the
day-to-day operations of the Hedrin JV. The joint venture entity has been
independently funded and will be responsible for all costs associated with
the
Hedrin project, including any necessary United States (“U.S.”) clinical trials,
patent costs, and future milestones owed to the original licensor,
T&R.
Pediculosis
(Head lice)
Head
lice
(Pediculus
humanus capitis)
are
small parasitic insects that live mainly on the human scalp and neck hair.
Head
lice are not known to transmit disease, but they are highly contagious and
are
acquired by direct head-to-head contact with an infested person’s hair, and may
also be transferred with shared combs, hats, and other hair accessories.
They
can also live on bedding or upholstered furniture for a brief period. Head
lice
are seen across the socioeconomic spectrum and are unrelated to personal
cleanliness or hygiene. Children are more frequently infested than are adults,
and Caucasians more frequently than other ethnic groups. Lice are most commonly
found on the scalp, behind the ears, and near the neckline at the back of
the
neck. Common symptoms include a tickling feeling of something moving in the
hair, itching, irritability caused by poor sleep, and sores on the head caused
by scratching. According to our internal analysis, a majority of the currently
available prescription and over-the-counter (“OTC”) head lice treatments are
chemical insecticides.
Mechanism
of Action
Hedrin
is
a novel, non-insecticide combination of silicones (dimethicone and
cyclomethicone) that acts as a pediculicidal (lice killing) agent by disrupting
the insect’s mechanism for managing fluid and breathing. In contrast with most
currently available lice treatments, Hedrin contains no chemical insecticides.
Because Hedrin kills lice by preventing the louse from excreting waste fluid
and
by asphyxiation (smothering), rather than by acting on the central nervous
system, the insects have not build up resistance to the treatment. Recent
studies have indicated that resistance to chemical insecticides may be
increasing and therefore contributing to insecticide treatment failure.
Manhattan Pharmaceuticals believes there is significant market potential
for
convenient, non-insecticide treatment alternatives. Both silicones in this
proprietary formulation of Hedrin are used extensively in cosmetics and
toiletries.
Clinical
Development
To
date,
Hedrin has been clinically studied in 326 subjects and is currently marketed
as
a medical device in Western Europe and as a pharmaceutical in the United
Kingdom
(“U.K.”).
In
a
randomized, controlled, equivalence, clinical study (conducted in Europe),
Hedrin was administered to 253 adult and child subjects with head lice
infestation. The study results, published in the British Medical Journal
in June
2005, demonstrated Hedrin’s equivalence when compared to the insecticide
treatment, phenothrin, the most widely used pediculicide in the U.K. In
addition, according to the same study, the Hedrin treated subjects experienced
significantly less irritation (2%) than those treated with phenothrin
(9%).
An
additional clinical study published in the November 2007 issue of PLoS One,
an
international, peer-reviewed journal published by the Public Library of Science
(PLoS), demonstrated Hedrin’s superior efficacy compared to a U.K. formulation
of malathion, a widely used insecticide treatment in both Europe and North
America. In this randomized, controlled, assessor blinded, parallel group
clinical trial, 73 adult and child subjects with head lice infestations were
treated with Hedrin or malathion liquid. Using intent-to-treat analysis,
Hedrin
achieved a statistically significant cure rate of 70% compared to 33% with
malathion liquid. Using the per-protocol analysis Hedrin achieved a highly
statistically significant cure rate of 77% compared to 35% with malathion.
In
Europe, it has been widely documented that head lice has become resistant
to
malathion, and we believe this resistance may have influenced the study results.
To date, there have been no reports of malathion resistance in the U.S.
Additionally, Hedrin treated subjects experienced no irritant reactions,
and
Hedrin showed clinical equivalence to malathion in its ability to inhibit
egg
hatching. Overall, investigators and study subjects rated Hedrin as less
odorous, easier to apply, and easier to wash out, and 97% of Hedrin treated
subjects stated they were significantly more inclined to use the product
again
versus 31% of those using malathion.
3
In
the
U.S., Manhattan Pharmaceuticals, through the Hedrin JV, is pursuing the
development of Hedrin as a medical device and has submitted an initial
regulatory package to the U.S. Food and Drug Administration (“FDA”) Center for
Devices and Radiological Health. The Company expects to be required to complete
at least one clinical trial with this product candidate.
Market
and Competition
In
Europe, Hedrin has been launched in 21 countries and has achieved annual
sales
through its licensees of approximately $45 million at in-market public prices,
and is the market leader in the U.K. with $11 million in sales (23% market
share) and France with a 21% market share. These figures do not include sales
in
Germany, Spain and Greece where Hedrin was launched in mid-late
2007.
According
to the American Academy of Pediatrics an estimated 6-12 million Americans
are
infested with head lice each year, with pre-school and elementary children
and
their families affected most often. The total U.S. head lice market is estimated
to be over $200 million with prescription and over-the-counter (OTC) therapies
comprising approximately 50% of that market. The remaining 50% of the market
is
comprised of alternative therapies such as tea tree oils, mineral oils, and
“nit
picking”, or physical combing to remove lice. We believe there is significant
market potential for a convenient, non-insecticide treatment for head
lice.
The
prescription and OTC segment of the market is dominated by 4-5 name brand
products and numerous, low cost generics and store brand equivalents. The
active
ingredients in these pharmacological therapies are chemical insecticides.
The
most frequently prescribed insecticide treatments are Kwell (lindane) and
Ovide
(malathion), and the most frequently purchased OTC brands are Rid (pyrethrin),
Nix (permethrin), and Pronto (pyrethrin). Lindane has been banned in 52
countries worldwide and has now been banned in the state of California due
to
its toxicity. European formulations of Malathion have experienced widespread
resistance. Resistance to U.S. formulations of malathion have not been widely
reported, but experts believe it may eventually develop with continued use.
Head
lice resistance to pyrethrin and permethrin has been reported in the U.S.
and
treatment failures are common.
See
also “Management’s Discussion and Analysis of Financial Condition and Results of
Operations- Liquidity and Capital Resources- Research and Development Projects-
Hedrin.”
Topical
PTH (1-34)
As
a
result of our merger with Tarpan Therapeutics in 2005, we hold an exclusive,
worldwide license to develop and commercialize Topical PTH (1-34) for the
treatment of psoriasis. Tarpan acquired the exclusive, worldwide rights pursuant
to a 2004 license agreement with IGI, Inc (“IGI”). Topical PTH (1-34) has been
tested in a Phase 1/2 clinical study conducted under a physician investigational
new drug application (“P-IND”).
4
Psoriasis
Psoriasis
is a common, chronic, immune-mediated disease that results in the
over-production of skin cells. In healthy skin, immature skin cells migrate
from
the lowest layer of the epidermis to the skin’s surface over a period of 28-30
days. In psoriasis, these cells reproduce at an extremely accelerated rate
and
advance to the surface in only 7 days. This results in a build up of excess,
poorly differentiated skin cells that accumulate in dry, thick patches known
as
plaques. These plaques can appear anywhere on the body resulting in skin
irritation and disability.
Mechanism
of Action
It
is
believed that Topical PTH (1-34) is an agonist that mimics a natural protein
responsible for regulating the growth of skin cells. The presence of this
natural protein, PTHrp, is significantly reduced in the skin of psoriasis
patients leading to skin cell hyperproliferation, poor differentiation of
skin
cells, and ultimately, the accumulation of dry thick patches of skin (plaques).
Acting in place of the absent PTHrp, it is also believed that Topical PTH
(1-34)
is able to help restore skin cells’ normal rate of development, migration and
turnover, reducing cell accumulation and the formation of plaques.
Clinical
Development
In
2003,
researchers, led by Michael Holick, MD, PhD, Professor of Medicine, Physiology,
and Biophysics at Boston University Medical Center, reported positive results
from a US Phase 1 and 2 clinical trial conducted under a P-IND evaluating
the
safety and efficacy of Topical PTH (1-34) as a topical treatment for psoriasis.
This double-blind, placebo controlled trial in 15 patients compared Topical
PTH
(1-34) formulated in the Novasome® Technology versus the Novasome® vehicle
alone. Following 8 weeks of treatment, the topical application of Topical
PTH
(1-34) resulted in complete clearing of the treated lesion in 60% of patients
and partial clearing in 85% of patients. Additionally, there was a statistically
significant improvement in the global severity score. Ten patients continued
receiving Topical PTH (1-34) in an open label extension study in which the
Psoriasis Area and Severity Index (PASI) was measured; PASI improvement across
all 10 patients achieved statistically significant improvement compared to
baseline. This study showed Topical PTH (1-34) to be well tolerated and
efficacious for the treatment of plaque psoriasis with no patients experiencing
any clinically significant adverse events.
Due
to
the high response rate seen in patients in the initial trial with Topical
PTH
(1-34), we believe that it may have an important clinical advantage over
current
topical psoriasis treatments. A Phase 2a clinical study testing Topical PTH
(1-34) under a P-IND was initiated in December 2005 under the auspices of
Boston
University. In April 2006, and prior to dosing subjects, we reported a delay
in
our Phase 2a clinical study of Topical PTH (1-34) due to a formulation issue.
We
believe we have resolved this issue through a new gel formulation of Topical
PTH
(1-34) and have filed new patent applications in the U.S. for this new
proprietary formulation.
In
September 2007, the U.S. FDA accepted our corporate Investigational New Drug
(“IND”) application for this new gel formulation of Topical PTH (1-34), and in
October 2007, we initiated and began dosing subjects in a Phase 2a clinical
study of Topical PTH (1-34) for the treatment of psoriasis. This U.S.,
multi-center, randomized, double-blind, vehicle-controlled, parallel group
study
is designed to evaluate safety and preliminary efficacy of Topical PTH (1-34)
for the treatment of psoriasis. Approximately 54 subjects will be enrolled
and
randomized to receive one of two dose levels of Topical PTH (1-34), or vehicle,
for an 8 week treatment period. In this study the vehicle is the topical
formulation without the active ingredient, PTH (1-34). We expect to announce
the
results of this study in Summer 2008.
5
Market
and Competition
According
to the National Psoriasis Foundation nearly 2% of the worldwide population,
including approximately 4.5 million Americans, suffers from psoriasis. In
the
U.S. psoriasis patients are responsible for nearly 2.4 million visits to
dermatologists each year at an annual cost of nearly $3 billion. Manhattan
Pharmaceuticals estimates the U.S. topical psoriasis therapeutics market
to be
approximately $400-500 million, with the market throughout the rest of the
world
in the same range.
The
efficacy and safety profile of Topical PTH (1-34) potentially make it an
attractive alternative to existing topical treatments, photo therapies and
systemic treatments such as methotrexate and biologics for the treatment
of
psoriasis. We are developing Topical PTH (1-34) as a monotherapy and for
use in
combination with currently available therapies. Some of Topical PTH (1-34)’s
competitors would include, but are not limited to over-the-counter, or “OTC,”
prescription topical treatments, and laser treatment. Treatments such as
phototherapy, methotrexate, cyclosporine, Remicade®
(Johnson
& Johnson), Enbrel®
(Amgen),
Amiveve®
(Astellas), and Raptiva®
(Genentech) are generally used for more severe patients due to their harsh
side
effect profiles.
There
are
a number of treatments available today for psoriasis, including topicals
and
steroids. Topical treatments include numerous OTC ointments that help to
reduce
inflammation, soothe skin and enhance the efficacy of other therapies. Steroids
are also prescribed as an adjunct therapy for pain and anti-inflammation.
One of
the most frequently prescribed topical treatments is Dovonex®
(calcipotriene), which is an active vitamin D3 analogue. Approximately 60%
of
patients show some response to Dovonex®
in the
first few months of treatment, however, 60% of these patients become resistant
to treatment in 6-12 months. Dovonex®
sales in
the US in 2006 were $147 million
See
also “Management’s Discussion and Analysis of Financial Condition and Results of
Operations - Liquidity and Capital Resources - Research and Development Projects
– Topical PTH (1-34).”
Altoderm™
In
April
2007 we entered into a license agreement with T&R, pursuant to which we
acquired exclusive rights to develop and commercialize Altoderm in North
America. Altoderm is
a
novel, proprietary formulation of topical cromolyn sodium and is designed
to
enhance the absorption of cromolyn sodium into the skin in order to treat
pruritus (itch) associated with dermatologic conditions including atopic
dermatitis (eczema).
Atopic
Dermatitis (Eczema)
Atopic
dermatitis, also know as eczema, is a chronic disease of the skin that is
believed to be caused by a combination of hereditary and environmental factors.
The main symptoms of atopic dermatitis include dry, itchy skin leading to
rashes
on the face, hands, feet, along with inside the elbows and behind the knees.
Scratching results in redness, swelling, cracking, “weeping” clear fluid, and
crusting or scaling.
Mechanism
of Action
Altoderm
is a topical formulation of cromolyn sodium, a non-steroidal, anti-inflammatory
agent that is categorized as a mast cell stabilizer. Cromolyn sodium has
been
shown to block allergic reactions by inhibiting the release of inflammatory
mediators, including histamine and leukotrienes. Elevated levels of these
agents
result in local and systemic inflammation that, in turn, leads to conditions
such as atopic dermatitis. By reducing the release of inflammatory agents
by
mast cells, Manhattan Pharmaceuticals believes that Altoderm may effectively
treat patients suffering from pruritus associated with atopic dermatitis,
and
possibly other dermatologic conditions. Cromolyn sodium has been used worldwide
for over 35 years to treat a number of allergic conditions includin asthma,
allergic rhinitis (nasal allergies), allergic conjunctivitis (eye allergies),
and internal allergic conditions such as mastocytosis.
6
Clinical
Development
In
a
Phase 3, randomized, double-blind, placebo-controlled, parallel-group, clinical
study (conducted in Europe by T&R.) the compound was administered for 12
weeks to 114 subjects with moderately severe atopic dermatitis. The placebo
(vehicle) used in this study was the Altoderm product without the active
ingredient. In the study results, published in the British Journal of
Dermatology in February 2005, Altoderm demonstrated a statistically significant
reduction (36%) in atopic dermatitis symptoms. During the study, subjects
were
permitted to continue with their existing treatment, in most cases this
consisted of emollients and topical steroids. A positive secondary outcome
of
the study was a 35% reduction in the use of topical steroids for the Altoderm
treated subjects. Further analysis of the clinical data, performed by Manhattan
Pharmaceuticals, showed that Altoderm treated subjects also experienced a
57%
reduction in pruritus.
Altoderm
is currently being tested in a second, ongoing Phase 3, randomized,
double-blind, vehicle-controlled clinical study (also conducted in Europe
by
T&R). Analysis of the preliminary data from the initial 12 week, blinded
portion of this clinical trial has been completed. The vehicle used in this
study was the Altoderm product without the active ingredient, cromolyn sodium.
The preliminary data indicate Altoderm was safe and well tolerated, and showed
a
trend toward improvement in pruritus, but the efficacy results were
inconclusive. Altoderm treated subjects and vehicle only treated subjects
experienced a similar improvement (each greater than 30%), and therefore,
the
study did not achieve statistical significance. The Company believes these
outcomes were due to suboptimal study design where subjects were unrestricted
in
their use of concomitant therapies such as topical steroids and
immunomodulators. In this study subjects treated with vehicle alone in the
blinded portion of the study were switched to Altoderm for the open label
portion of the study. Analysis of the preliminary open label data beginning
at
week 13 of the study, show vehicle treated subjects demonstrating further
improvement when switched to Altoderm. Given the promising clinical data
obtained from the first European Phase 3 study, and the symptom improvements
reported in the ongoing European Phase 3 study, both Manhattan Pharmaceuticals
and T&R believe there is significant potential for Altoderm and will
continue development of this product candidate.
On
March
6, 2008, Manhattan Pharmaceuticals announced it had successfully completed
a
pre-IND meeting with the FDA. Based on a review of the submitted package
for
Altoderm, including data from the two previously reported Phase 3 clinical
studies, the FDA determined that following completion of certain nonclinical
studies, and the acceptance of an IND, Phase 2 clinical studies may be initiated
in the U.S. The FDA also concurred that the proposed indication of pruritus
associated with dermatologic conditions including atopic dermatitis can be
pursued.
Market
and Competition
According
to the National Institutes of Health, an estimated 10-20% of all infants
and
young children and 1-3% of adults have atopic dermatitis (eczema). This
translates to approximately 15 million Americans suffering from the disease.
Insurance companies spend more than $1 billion annually on the condition.
7
Topical
steroids, topical immunomodulators, systemic antihistamines, and moisturizing
agents are currently the primary pharmaceutical treatments for atopic
dermatitis. However, these products are not meeting the needs of patients
due to
unwanted side effects including skin thinning, acne, hypopigmentation, and
secondary infection, among others, and limited evidence to support their
long
term safety. Based on these limitations of current atopic dermatitis treatments,
there is a significant market opportunity for new, effective
therapies.
See
also “Management’s Discussion and Analysis of Financial Condition and Results of
Operations- Liquidity and Capital Resources- Research and Development Projects-
Altoderm.”
Altolyn™
In
April
2007 we entered into a license agreement with T&R, pursuant to which we
acquired exclusive rights to develop and commercialize Altolyn in North America.
Altolyn is
a
novel, proprietary oral tablet formulation of cromolyn sodium designed to
treat
mastocytosis and possibly other gastrointestinal disorders such as food allergy
and symptoms of irritable bowel syndrome.
Mastocytosis
Mastocytosis
is a rare disorder that occurs in both children and adults. It is caused
by the
presence of too many mast cells in the body. Mast cells are found in skin,
linings of the stomach and intestine, and connective tissue (such as cartilage
and tendons). Mast cells play an important role in helping the immune systems
defend these tissues from disease. They release chemical “alarms” such as
histamine and cytokines to attract other key players of the immune defense
system to sites in the body where they might be needed. People with mastocytosis
experience abdominal discomfort, nausea and vomiting, ulcers, diarrhea, and
skin
lesions.
Mechanism
of Action
Altolyn
is a novel oral tablet formulation of cromolyn sodium that has been formulated
using site specific drug delivery technology. This unique formulation targets
release of the drug in the upper region of the small intestine. Cromolyn
sodium,
which has been used for more than 35 years to treat a variety of allergic
conditions, is a mast cell stabilizer that reduces mast cell activation and
decreases the release of inflammatory mediators.
Nonclinical
Development
On
March
6, 2008, Manhattan Pharmaceuticals announced it had successfully completed
a
pre-IND meeting with the FDA. Based on a review of the submitted package
for
Altolyn, the FDA concurred that the proposed indication of mastocytosis can
be
pursued and that the 505(b)(2) NDA would be an acceptable approach provided
a
clinical bridge is established between Altolyn and Gastrocrom®, the oral liquid
formulation of cromolyn sodium currently approved in the U.S. to treat
mastocytosis. Section 505(b)(2) of the Food, Drug and Cosmetic Act allows
the
FDA to approve a follow-on drug on the basis of data in the scientific
literature or data used by FDA in the approval of other drugs.The FDA also
affirmed that a single, Phase 3 study demonstrating the efficacy of Altolyn
over
placebo, may be sufficient to support a product approval in the U.S. In
addition, the FDA also concurs that no additional nonclinical studies will
be
required to support an IND application. The Company is working with T&R and
the current U.K. manufacturer of Altolyn to develop a Good Manufacturing
Process
(“cGMP”) compliant manufacturing process.
8
Early
clinical experience with Altolyn in the U.K. suggests promising activity
in
patients with various allergic disorders, including food allergy and
inflammatory bowel conditions. The Company may pursue these as additional
indications.
See
also “Management’s Discussion and Analysis of Financial Condition and Results of
Operations- Liquidity and Capital Resources- Research and Development Projects-
Altolyn.”
Oleoyl-estrone
On
July
9, 2007 the Company announced the results of its two Phase 2a clinical trials
of
oral Oleoyl-estrone (“OE”). The results of both randomized, double-blind,
placebo controlled studies, one in common obesity and the other in morbid
obesity, demonstrated no statistically or clinically meaningful placebo adjusted
weight loss for any of the treatment arms evaluated. Based on these results,
the
Company discontinued its OE programs in both common obesity and morbid
obesity.
Propofol
Lingual Spray
On
July
9, 2007 the Company announced that it discontinued development of Propofol
Lingual Spray for pre-procedural sedation.
Intellectual
Property and License Agreements
Our
goal
is to obtain, maintain and enforce patent protection for our products,
formulations, processes, methods and other proprietary technologies, preserve
our trade secrets, and operate without infringing on the proprietary rights
of
other parties, both in the United States and in other countries. Our policy
is
to actively seek to obtain, where appropriate, the broadest intellectual
property protection possible for our product candidates, proprietary information
and proprietary technology through a combination of contractual arrangements
and
patents, both in the U.S. and elsewhere in the world.
We
also
depend upon the skills, knowledge and experience of our scientific and technical
personnel, as well as that of our advisors, consultants and other contractors.
none This knowledge and experience we call “know-how”. To help protect our
proprietary know-how which is not patentable, and for inventions for which
patents may be difficult to enforce, we rely on trade secret protection and
confidentiality agreements to protect our interests. To this end, we require
all
employees, consultants, advisors and other contractors to enter into
confidentiality agreements which prohibit the disclosure of confidential
information and, where applicable, require disclosure and assignment to us
of
the ideas, developments, discoveries and inventions important to our
business.
Hedrin
On
June
26, 2007, the Company entered into an exclusive license the Hedrin agreement
with T&R and Kerris. Pursuant to the Hedrin License Agreement, the Company
has acquired an exclusive North American license to certain patent rights
and
other intellectual property relating to HedrinTM,
a
non-insecticide product candidate for the treatment of pediculosis (“head
lice”):
1.
|
U.S.
Patent Application No. 2007/0142330, entitled, “Method and composition for
the control of arthropods.” Jayne Ansell, Inventor. Application filed
February 12, 2007. This application is a divisional of U.S. application
Ser. No. 10/097,615, filed Mar. 15, 2002, which is a continuation
of
International Application No. PCT/GB00/03540, which designated
the United
States and was filed on Sep. 14, 2000. This application has not
yet issued
as a patent. Any patent that issues will expire on September14,
2020.
|
9
This
patent application has numerous, detailed and specific claims related to
the use
of Hedrin (novel formulation of silicon derivatives) in controlling and
repelling arthropods such as insects and arachnids, and in particular control
and eradication of head lice and their ova.
In
addition, on June 26, 2007, the Company entered into the Hedrin Supply Agreement
with T&R pursuant to which T&R will be the Company’s exclusive supplier
of the Hedrin product.
In
consideration for the license, the Company issued to T&R and Kerris
(jointly, the “Licensor”) a combined total of 150,000 shares of its common stock
valued at $120,000. In addition, the Company also made a cash payment of
$600,000 to the Licensor. Further, the Company agreed to make future milestone
payments to the Licensor comprised of various combinations of cash and common
stock in respective aggregate amounts of $2,500,000 upon the achievement
of
various clinical and regulatory milestones as follows: $250,000 upon acceptance
by the FDA of an IND; $1,000,000 upon the achievement of a successful outcome
of
a Phase 3 clinical trial; $700,000 upon the final approval of a New Drug
Application (“NDA”), or its equivalent, by the FDA; $300,000 upon the issuance
of a U.S. patent on Hedrin: and $250,000 upon receipt of marketing authorization
in Canada.
Through
December 31, 2007, none of the milestones have been reached and sales have
not
commenced, therefore, we have not paid any such milestones or
royalties.
The
Company also agreed to pay royalties to the Licensor of 8% (or, under certain
circumstances, 4%) on net sales of licensed products. The Company’s exclusivity
under the Hedrin Agreement is subject to an annual minimum royalty payment
of
$1,000,000 (or, under certain circumstances, $500,000) in each of the third
through seventh years following the first commercial sale of Hedrin. The
Company
may sublicense its rights under the Hedrin Agreement with the consent of
Licensor and the proceeds resulting from such sublicenses will be shared
with
the Licensor.
Pursuant
to the Hedrin Supply Agreement, the Company has agreed that it and its
sublicensees will purchase their respective requirements of the Hedrin product
from T&R at agreed upon prices. Under certain circumstances where T&R is
unable to supply Hedrin products in accordance with the terms and conditions
of
the Supply Agreement, the Company may obtain product from an alternative
supplier subject to certain conditions. The term of the Supply Agreement
ends
upon termination of the Hedrin Agreement.
On
February 25, 2008 the Company assigned and transferred its rights in Hedrin
to
the Hedrin JV.
The
Hedrin JV is now responsible for all of the Company’s obligations under the
Hedrin License Agreement and the Hedrin Supply Agreement.
Topical
PTH (1-34) License Agreement.
In
connection with our April 2005 acquisition of Tarpan Therapeutics, Inc.,
we
acquired Tarpan’s rights under an April 2004 Sublicense Agreement with IGI, Inc.
(the “IGI Agreement”). Pursuant to this agreement we now have worldwide,
exclusive license rights to the U.S. and foreign patents and patent applications
for all topical uses of Topical PTH(1-34) for the treatment of
hyperproliferative skin disorders including psoriasis:
1.
|
U.S.
Patent No. 5,527,772, entitled “Regulation of cell proliferation and
differentiation using peptides.” M.F. Holick, Inventor. Application filed
July, 28, 1994. Patent issued June 18, 1996. This patent expires
June 18,
2013.
|
10
2.
|
U.S.
Patent No. 5,840,690, entitled “Regulation of cell proliferation and
differentation using peptides.” M.F. Holick, Inventor. Application filed
June 6, 1995. Patent issued November 24, 1998. This patent expires
June
18, 2013.
|
3.
|
U.S.
Provisional application No. US60/940,509, entitled “Topical Compositions
comprising a macromolecule and methods of using same.” Application was
filed on May 29, 2007.
|
These
patents have numerous, detailed and specific claims relating to the topical
use
of Topical PTH (1-34)
The
IGI
sublicense agreement requires us to make certain milestone payments as follows:
$300,000 payable upon the commencement of a Phase 2 clinical trial; $500,000
upon the commencement of a Phase 3 clinical trial; $1,500,000 upon the
acceptance of an Investigational New Drug Application (“NDA”) by the FDA;
$2,400,000 upon the approval of an NDA by the FDA; $500,000 upon the
commencement of a Phase 3 clinical trial for an indication other than psoriasis;
$1,500,000 upon the acceptance of and NDA application for an indication other
than psoriasis by the FDA; and $2,400,000 upon the approval of an NDA for
an
indication other than psoriasis by the FDA.
During
2007 we achieved the milestone of the commencement of a Phase 2 clinical
trial.
As a result $300,000 became payable to IGI. This $300,000 is included in
research and development expense for the year ended December 31, 2007. Payment
was made to IGI in February 2008. At December 31, 2008 this $300,000 liability
is reflected in accounts payable.
In
addition, we are obligated to pay IGI, Inc. an annual royalty of 6% on annual
net sales up to $200,000,000. In any calendar year in which net sales exceed
$200,000,000, we are obligated to pay IGI, Inc. an annual royalty of 9% annual
net sales. Through December 31, 2007 sales have not commenced, therefore
we have
not paid any such royalties.
IGI,
Inc.
may terminate the agreement (i) upon 60 days’ notice if we fail to make any
required milestone or royalty payments, or (ii) if we become bankrupt or
if a
petition in bankruptcy is filed, or if we are placed in the hands of a receiver
or trustee for the benefit of creditors. IGI, Inc. may terminate the agreement
upon 60 days’ written notice and an opportunity to cure in the event we commit a
material breach or default. We may terminate the agreement in whole or as
to any
portion of the PTH patent rights upon 90 days’ notice to IGI, Inc.
Altoderm
On
April
3, 2007, the Company entered into a license agreement for Altoderm (the
“Altoderm Agreement”) with T&R. Pursuant to the Altoderm Agreement, the
Company acquired an exclusive North American license to certain patent rights
and other intellectual property relating to Altoderm, a topical skin lotion
product candidate with the active ingredient cromolyn sodium (also known
as
sodium cromoglicate) for the treatment of pruritis (itch) associated with
dermatologic conditions including atopic dermatitis:
1.
|
U.S.
Patent No. 7,109,246, entitled “Pharmaceutical compositions comprising an
amphoteric surfactant an alkoxylated cetyl alcohol and a polar
drug.”
Brian Hawtin, Inventor. Application filed May 20, 1999. Patent
issued
September 19, 2006. This patent expires on May 20,
2019.
|
2.
|
U.S.
Application Publication No. 2007/0036860, entitled “Treatment of allergic
conditions.” Alexander James Wigmore, Inventor. Any patent that issues
will expire on November 9, 2019. This patent covers both Altoderm
and
Altolyn.
|
11
These
patents have numerous, detailed and specific claims related to the use of
Altoderm (composition of topically administered cromolyn sodium) for treating
atopic dermatitis (eczema).
In
accordance with the terms of the Altoderm Agreement, the Company issued 125,000
shares of its common stock, valued at $112,500, and made a cash payment of
$475,000 to T&R upon the execution of the agreement. Further, the Company
agreed to make future milestone payments to T&R comprised of various
combinations of cash and common stock in respective aggregate amounts of
$5,675,000 and 875,000 shares of our common stock upon the achievement of
various clinical and regulatory milestones. as follows: $450,000 upon acceptance
by FDA of an IND; 125,000 shares of our common stock upon the first dosing
of a
patient in the first Phase 2 clinical trial; 250,000 shares of our common
stock
and $625,000 upon the first dosing of a patient in the first Phase 3 clinical
trial; $1,000,000 upon the achievement of a successful outcome of a Phase
3
clinical trial; $1,100,000 upon the acceptance for filing of a NDA application
by the FDA; 500,000 shares of our common stock and $2,000,000 upon the final
approval of an NDA by the FDA; and $500,000 upon receipt of marketing
authorization in Canada.
In
addition, we are obligated to pay T&R an annual royalty of 10% on annual net
sales of up to $100,000,000; 15% of the amount of annual net sales in excess
of
$100,000,000 and 20% of annual net sales in excess of $200,000,000. There
is a
minimum royalty of $1,000,000 per year. There is a one-time success fee of
$10,000,000 upon the achievement of cumulative net sales of $100,000,000.
Through December 31, 2007, none of the milestones have been reached and sales
have not commenced, therefore, we have not paid any such milestones or
royalties.
Altolyn
On
April
3, 2007, the Company and T&R also entered into a license agreement for
Altolyn (the “Altolyn Agreement”). Pursuant to the Altolyn Agreement, the
Company acquired an exclusive North American license to certain patent rights
and other intellectual property relating to Altolyn, an oral tablet formulation
product candidate using sodium cromolyn for the treatment of mastocytosis,
food
allergies, and inflammatory bowel disorder.
1.
|
U.S.
Patent No. 7,258,872, entitled “Chromone enteric release formulation.”
Alexander James Wigmore, Inventor. Application filed November 9,
1999,
claiming the benefit of a GB application filed November 11, 1998.
Patent
issued August 21, 2007. The expected date of expiration, which
was
November 9, 2019, has been extended by 793 days (expiration date
Jan 10,
2022).
|
2.
|
U.S.
Application Publication No. 2007/0036860, entitled “Treatment of allergic
conditions.” Alexander James Wigmore, Inventor. Application filed October
13, 2006, claiming the benefit of a prior U.S. application, which
claimed
the benefit of a PCT application filed November 9, 1999. This application
has not yet issued as a patent. Any patent that issues is expected
to
expire on November 9, 2019. This patent covers both Altoderm and
Altolyn.
|
These
patents have numerous, detailed and specific claims related to Altolyn (as
an
oral tablet drug delivery composition), and the pending application discloses
and may be used to claim the use of Altolyn (composition of orally administered
sodium cromolyn) for the treatment of allergic conditions, specifically food
allergies.
In
accordance with the terms of the Altolyn Agreement, the Company made a cash
payment of $475,000 to T&R upon the execution of the agreement. Further, the
Company agreed to make future milestone payments to T&R comprised of various
combinations of cash and common stock in respective aggregate amounts of
$5,675,000 upon the achievement of various clinical and regulatory milestones.
as follows: $450,000 upon acceptance filing by the FDA of an IND; $625,000
upon
the first dosing of a patient in the first Phase 3 clinical trial; $1,000,000
upon the achievement of a successful outcome of a Phase 3 clinical trial;
$1,100,000 upon the acceptance for filing of a NDA application by the FDA;
$2,000,000 upon the final approval of an NDA by the FDA; and $500,000 upon
receipt of marketing authorization in Canada.
12
In
addition, we are obligated to pay T&R an annual royalty of 10% on annual net
sales of up to $100,000,000; 15% of the amount of annual net sales in excess
of
$100,000,000 and 20% of annual net sales in excess of $200,000,000. There
is a
minimum royalty of $1,000,000 per year. There is a one-time success fee of
$10,000,000 upon the achievement of cumulative net sales of $100,000,000.
Through December 31, 2007, none of the milestones have been reached and sales
have not commenced, therefore, we have not paid any such milestones or
royalties.
Oleoyl-estrone
On
July
9, 2007 the Company announced the results of its two Phase 2a clinical trials
of
oral OE. The results of both randomized, double-blind, placebo controlled
studies, one in common obesity and the other in morbid obesity, demonstrated
no
statistically or clinically meaningful placebo adjusted weight loss for any
of
the treatment arms evaluated. Based on these results, the Company discontinued
its OE programs in both common obesity and morbid obesity.
Propofol
Lingual Spray
On
July
9, 2007 the Company announced that it discontinued development of Propofol
Lingual Spray for pre-procedural sedation.
Manufacturing
We
do not
have any manufacturing capabilities. We are in contact with several contract
cGMP manufacturers for the supply of Topical PTH(1-34), Hedrin, Altoderm
and
Altolyn that will be necessary to conduct human clinical trials.
Government
Regulation
The
research, development, testing, manufacture, labeling, promotion, advertising,
distribution, and marketing, among other things, of our products are extensively
regulated by governmental authorities in the United States and other countries.
In the United States, the FDA regulates drugs under the Federal Food, Drug,
and
Cosmetic Act, or the FDCA, and its implementing regulations. Failure to comply
with the applicable U.S. requirements may subject us to administrative or
judicial sanctions, such as FDA refusal to approve pending NDAs, warning
letters, product recalls, product seizures, total or partial suspension of
production or distribution, injunctions, and/or criminal prosecution.
Drug
Approval Process. None
of
our drugs may be marketed in the U.S. until the drug has received FDA approval.
The steps required before a drug may be marketed in the U.S. include:
· |
nonclinical
laboratory tests, animal studies, and formulation
studies,
|
13
· |
submission
to the FDA of an IND for human clinical testing, which must become
effective before human clinical trials may
begin,
|
· |
adequate
and well-controlled human clinical trials to establish the safety
and
efficacy of the drug for each
indication,
|
· |
submission
to the FDA of an NDA,
|
· |
satisfactory
completion of an FDA inspection of the manufacturing facility or
facilities at which the drug is produced to assess compliance with
current
good manufacturing practices, or cGMPs,
and
|
· |
FDA
review and approval of the NDA.
|
Nonclinical
tests include laboratory evaluation of product chemistry, toxicity, and
formulation, as well as animal studies. The conduct of the nonclinical tests
and
formulation of the compounds for testing must comply with federal regulations
and requirements. The results of the nonclinical tests, together with
manufacturing information and analytical data, are submitted to the FDA as
part
of an IND, which must become effective before human clinical trials may begin.
An IND will automatically become effective 30 days after receipt by the FDA,
unless before that time the FDA raises concerns or questions about issues
such
as the conduct of the trials as outlined in the IND. In such a case, the
IND
sponsor and the FDA must resolve any outstanding FDA concerns or questions
before clinical trials can proceed. We cannot be sure that submission of
an IND
will result in the FDA allowing clinical trials to begin.
Clinical
trials involve the administration of the investigational drug to human subjects
under the supervision of qualified investigators. Clinical trials are conducted
under protocols detailing the objectives of the study, the parameters to
be used
in monitoring safety, and the effectiveness criteria to be evaluated. Each
protocol must be submitted to the FDA as part of the IND.
Clinical
trials typically are conducted in three sequential phases, but the phases
may
overlap. The study protocol and informed consent information for study subjects
in clinical trials must also be approved by an Institutional Review Board
for
each institution where the trials will be conducted. Study subjects must
sign an
informed consent form before participating in a clinical trial. Phase 1 usually
involves the initial introduction of the investigational drug into people
to
evaluate its short-term safety, dosage tolerance, metabolism, pharmacokinetics
and pharmacologic actions, and, if possible, to gain an early indication
of its
effectiveness. Phase 2 usually involves trials in a limited patient population
to (i) evaluate dosage tolerance and appropriate dosage; (ii) identify possible
adverse effects and safety risks; and (iii) preliminarily evaluate the efficacy
of the drug for specific indications. Phase 3 trials usually further evaluate
clinical efficacy and test further for safety by using the drug in its final
form in an expanded patient population. There can be no assurance that Phase
1,
Phase 2, or Phase 3 testing will be completed successfully within any specified
period of time, if at all. Furthermore, we or the FDA may suspend clinical
trials at any time on various grounds, including a finding that the subjects
or
patients are being exposed to an unacceptable health risk.
The
FDCA
permits FDA and the IND sponsor to agree in writing on the design and size
of
clinical studies intended to form the primary basis of an effectiveness claim
in
an NDA application. This process is known as Special Protocol Assessment,
or
SPA. These agreements may not be changed after the clinical studies begin,
except in limited circumstances.
14
Assuming
successful completion of the required clinical testing, the results of the
nonclinical and clinical studies, together with other detailed information,
including information on the manufacture and composition of the drug, are
submitted to the FDA in the form of a NDA requesting approval to market the
product for one or more indications. The testing and approval process requires
substantial time, effort, and financial resources. The agencies review the
application and may deem it to be inadequate to support the registration
and we
cannot be sure that any approval will be granted on a timely basis, if at
all.
The FDA may also refer the application to the appropriate advisory committee,
typically a panel of clinicians, for review, evaluation and a recommendation
as
to whether the application should be approved. The FDA is not bound by the
recommendations of the advisory committee.
The
FDA
has various programs, including fast track, priority review, and accelerated
approval, that are intended to expedite or simplify the process for reviewing
drugs, and/or provide for approval on the basis surrogate endpoints. Generally,
drugs that may be eligible for one or more of these programs are those for
serious or life-threatening conditions, those with the potential to address
unmet medical needs, and those that provide meaningful benefit over existing
treatments. We cannot be sure that any of our drugs will qualify for any
of
these programs, or that, if a drug does qualify, that the review time will
be
reduced.
Section
505(b)(2) of the FDCA allows the FDA to approve a follow-on drug on the basis
of
data in the scientific literature or data used by FDA in the approval of
other
drugs. This procedure potentially makes it easier for generic drug manufacturers
to obtain rapid approval of new forms of drugs based on proprietary data
of the
original drug manufacturer. We intend to rely on Section 505(b)(2) to obtain
approval for Altolyn.
Before
approving an NDA, the FDA usually will inspect the facility or the facilities
at
which the drug is manufactured, and will not approve the product unless cGMP
compliance is satisfactory. If the FDA evaluates the NDA and the manufacturing
facilities as acceptable, the FDA may issue an approval letter, or in some
cases, an approvable letter followed by an approval letter. Both letters
usually
contain a number of conditions that must be met in order to secure final
approval of the NDA. When and if those conditions have been met to the FDA’s
satisfaction, the FDA will issue an approval letter. The approval letter
authorizes commercial marketing of the drug for specific indications. As
a
condition of NDA approval, the FDA may require post marketing testing and
surveillance to monitor the drug’s safety or efficacy, or impose other
conditions.
After
approval, certain changes to the approved product, such as adding new
indications, making certain manufacturing changes, or making certain additional
labeling claims, are subject to further FDA review and approval. Before we
can
market our product candidates for additional indications, we must obtain
additional approvals from FDA. Obtaining approval for a new indication generally
requires that additional clinical studies be conducted. We cannot be sure
that
any additional approval for new indications for any product candidate will
be
approved on a timely basis, or at all.
Post-Approval
Requirements.
Often
times, even after a drug has been approved by the FDA for sale, the FDA may
require that certain post-approval requirements be satisfied, including the
conduct of additional clinical studies. If such post-approval conditions
are not
satisfied, the FDA may withdraw its approval of the drug. In addition, holders
of an approved NDA are required to: (i) report certain adverse reactions
to the
FDA, (ii) comply with certain requirements concerning advertising and
promotional labeling for their products, and (iii) continue to have quality
control and manufacturing procedures conform to cGMP after approval. The
FDA
periodically inspects the sponsor’s records related to safety reporting and/or
manufacturing facilities; this latter effort includes assessment of compliance
with cGMP. Accordingly, manufacturers must continue to expend time, money,
and
effort in the area of production and quality control to maintain cGMP
compliance. We intend to use third party manufacturers to produce our products
in clinical and commercial quantities, and future FDA inspections may identify
compliance issues at the facilities of our contract manufacturers that may
disrupt production or distribution, or require substantial resources to correct.
In addition, discovery of problems with a product after approval may result
in
restrictions on a product, manufacturer, or holder of an approved NDA, including
withdrawal of the product from the market.
15
Orphan
Drug.
The FDA
may grant orphan drug designation to drugs intended to treat a “rare disease or
condition,” which generally is a disease or condition that affects fewer than
200,000 individuals in the United States. Orphan drug designation must be
requested before submitting an NDA. If the FDA grants orphan drug designation,
which it may not, the identity of the therapeutic agent and its potential
orphan
use are publicly disclosed by the FDA. Orphan drug designation does not convey
an advantage in, or shorten the duration of, the review and approval process.
If
a product that has an orphan drug designation subsequently receives the first
FDA approval for the indication for which it has such designation, the product
is entitled to orphan exclusivity, meaning that the FDA may not approve any
other applications to market the same drug for the same indication, except
in
certain very limited circumstances, for a period of seven years. Orphan drug
designation does not prevent competitors from developing or marketing different
drugs for that indication.
Non-United
States Regulation.
Before
our products can be marketed outside of the United States, they are subject
to
regulatory approval similar to that required in the United States, although
the
requirements governing the conduct of clinical trials, including additional
clinical trials that may be required, product licensing, pricing and
reimbursement vary widely from country to country. No action can be taken
to
market any product in a country until an appropriate application has been
approved by the regulatory authorities in that country. The current approval
process varies from country to country, and the time spent in gaining approval
varies from that required for FDA approval. In certain countries, the sales
price of a product must also be approved. The pricing review period often
begins
after market approval is granted. Even if a product is approved by a regulatory
authority, satisfactory prices may not be approved for such product.
In
Europe, marketing authorizations may be submitted at a centralized, a
decentralized or national level. The centralized procedure is mandatory for
the
approval of biotechnology products and provides for the grant of a single
marketing authorization that is valid in all European Union (“EU”) members
states. As of January 1995, a mutual recognition procedure is available at
the
request of the applicant for all medicinal products that are not subject
to the
centralized procedure. There can be no assurance that the chosen regulatory
strategy will secure regulatory approvals on a timely basis or at
all.
Employees
We
currently have 1 part time and 6 full time employees, including 1 person
devoted
to research and development and 6 persons in business development,
administration and finance, including our senior management. None of our
employees is covered by a collective bargaining unit. We believe our relations
with our employees is satisfactory.
16
Risk
Factors
An
investment in our securities is speculative in nature, involves a high degree
of
risk, and should not be made by an investor who cannot bear the economic
risk of
its investment for an indefinite period of time and who cannot afford the
loss
of its entire investment. You should carefully consider the following risk
factors and the other information contained elsewhere in this Annual Report
before making an investment in our securities.
Risks
Related to Our Business
We
currently have no product revenues and will need to raise additional funds
in
the future. If we are unable to obtain the funds necessary to continue our
operations, we will be required to delay, scale back or eliminate one or more of
our drug development programs.
We
have
generated no product revenues to date and will not until, and if, we receive
approval from the FDA and other regulatory authorities for our product
candidates. We have already spent substantial funds developing our potential
products and business, however, and we expect to continue to have negative
cash
flow from our operations for at least the next several years. As of December
31,
2007, we had $649,686 of cash and cash equivalents. We
received additional funding of approximately $2 million net from a joint
venture
agreement in February 2008. We will still have to raise substantial additional
funds to complete the development of our drug candidates and to bring them
to
market. Beyond the capital requirements mentioned above, our future capital
requirements will depend on numerous factors, including:
· |
the
results of any clinical trials;
|
· |
the
scope and results of our research and development
programs;
|
· |
the
time required to obtain regulatory
approvals;
|
· |
our
ability to establish and maintain marketing alliances and collaborative
agreements; and
|
· |
the
cost of our internal marketing
activities.
|
Additional
financing may not be available on acceptable terms, if at all. If adequate
funds
are not available, we will be required to delay, scale back or eliminate
one or
more of our drug development programs or obtain funds through arrangements
with
collaborative partners or others that may require us to relinquish rights
to
certain of our technologies or products that we would not otherwise
relinquish.
We
are not currently profitable and may never become
profitable.
We
have a
history of losses and expect to incur substantial losses and negative operating
cash flow for the foreseeable future, and we may never achieve or maintain
profitability. We have incurred losses in every period since our inception
on
August 6, 2001. For the year ended December 31, 2007 and for the period from
August 6, 2001 (inception) through December 31, 2007, we incurred net losses
applicable to common shares of $12,032,252, and $54,999,070 respectively.
Even
if we succeed in developing and commercializing one or more of our product
candidates, we expect to incur substantial losses for the foreseeable future
and
may never become profitable. We also expect to continue to incur significant
operating and capital expenditures and anticipate that our expenses will
increase substantially in the foreseeable future as we:
17
· |
continue
to undertake nonclinical development and clinical trials for our
product
candidates;
|
· |
seek
regulatory approvals for our product
candidates;
|
· |
implement
additional internal systems and infrastructure;
|
· |
lease
additional or alternative office facilities;
and
|
· |
hire
additional personnel.
|
We
also
expect to experience negative cash flow for the foreseeable future as we
fund
our operating losses and capital expenditures. As a result, we will need
to
generate significant revenues in order to achieve and maintain profitability.
We
may not be able to generate these revenues or achieve profitability in the
future. Our failure to achieve or maintain profitability could negatively
impact
the value of our common stock.
We
have a limited operating history upon which to base an investment decision.
We
are a
development-stage company and have not yet demonstrated any ability to perform
the functions necessary for the successful commercialization of any product
candidates. The successful commercialization of our product candidates will
require us to perform a variety of functions, including:
· |
continuing
to undertake nonclinical development and clinical
trials;
|
· |
participating
in regulatory approval processes;
|
· |
formulating
and manufacturing products; and
|
· |
conducting
sales and marketing activities.
|
Since
inception as Manhattan Research Development, Inc., our operations have been
limited to organizing and staffing, and acquiring, developing and securing
our
proprietary technology and undertaking nonclinical and clinical trials of
principal product candidates. These operations provide a limited basis for
you
to assess our ability to commercialize our product candidates and the
advisability of investing in our securities.
We
may not obtain the necessary U.S. or worldwide regulatory approvals to
commercialize our product candidates.
We
will
need FDA approval to commercialize our product candidates in the U.S. and
approvals from the FDA equivalent regulatory authorities in foreign
jurisdictions to commercialize our product candidates in those jurisdictions.
In
order to obtain FDA approval of any of our product candidates, we must first
submit to the FDA an IND, which will set forth our plans for clinical testing
of
our product candidates. In September 2007, the FDA accepted our IND for Topical
PTH(1-34). Our remaining three products, Hedrin, Altoderm, and Altolyn, are
currently considered pre-clinical. We are unable to estimate the size and
timing
of the clinical and non clinical trials required to bring our four product
candidates to market and, accordingly, cannot estimate the time when development
of these product candidates will be completed.
18
When
the
clinical testing for our product candidates is complete, we will submit to
the
FDA a NDA demonstrating that the product candidate is safe for humans and
effective for its intended use. This demonstration requires significant research
and animal tests, which are referred to as nonclinical studies, as well as
human
tests, which are referred to as clinical trials. Satisfaction of the FDA’s
regulatory requirements typically takes many years, depends upon the type,
complexity and novelty of the product candidate and requires substantial
resources for research, development and testing. We cannot predict whether
our
research and clinical approaches will result in drugs that the FDA considers
safe for humans and effective for indicated uses. The FDA has substantial
discretion in the drug approval process and may require us to conduct additional
nonclinical and clinical testing or to perform post-marketing studies. The
approval process may also be delayed by changes in government regulation,
future
legislation or administrative action or changes in FDA policy that occur
prior
to or during our regulatory review. Delays in obtaining regulatory approvals
may:
· |
delay
commercialization of, and our ability to derive product revenues
from, our
product candidates;
|
· |
impose
costly procedures on us; and
|
· |
diminish
any competitive advantages that we may otherwise
enjoy.
|
Even
if
we comply with all FDA requests, the FDA may ultimately reject one or more
of
our NDAs. We cannot be sure that we will ever obtain regulatory clearance
for
any of our product candidates. Failure to obtain FDA approval of any of our
product candidates will severely undermine our business by reducing our number
of salable products and, therefore, corresponding product revenues.
In
foreign jurisdictions, we must receive approval from the appropriate regulatory
authorities before we can commercialize our drugs. Foreign regulatory approval
processes generally include all of the risks associated with the FDA approval
procedures described above. We have not yet made any determination as to
which
foreign jurisdictions we may seek approval and have not undertaken any steps
to
obtain approvals in any foreign jurisdiction.
Clinical
trials are very expensive, time consuming and difficult to design and
implement.
Human
clinical trials are very expensive and difficult to design and implement,
in
part because they are subject to rigorous regulatory requirements. The clinical
trial process is also time consuming. We estimate that clinical trials of
our
product candidates will take at least several years to complete. Furthermore,
failure can occur at any stage of the trials, and we could encounter problems
that cause us to abandon or repeat clinical trials. The commencement and
completion of clinical trials may be delayed by several factors,
including:
· |
unforeseen
safety issues;
|
· |
determination
of dosing issues;
|
· |
lack
of effectiveness during clinical
trials;
|
· |
slower
than expected rates of patient
recruitment;
|
· |
inability
to monitor patients adequately during or after treatment;
and
|
· |
inability
or unwillingness of medical investigators to follow our clinical
protocols.
|
19
In
addition, we or the FDA may suspend our clinical trials at any time if it
appears that we are exposing participants to unacceptable health risks or
if the
FDA finds deficiencies in our IND submissions or the conduct of these
trials.
The
results of our clinical trials may not support our product candidate
claims.
Even
if
our clinical trials are completed as planned, we cannot be certain that their
results will support our product candidate claims. Success in nonclinical
testing and early clinical trials does not ensure that later clinical trials
will be successful, and we cannot be sure that the results of later clinical
trials will replicate the results of prior clinical trials and nonclinical
testing. The clinical trial process may fail to demonstrate that our product
candidates are safe for humans or effective for indicated uses. This failure
would cause us to abandon a product candidate and may delay development of
other
product candidates. Any delay in, or termination of, our clinical trials
will
delay the filing of our NDAs with the FDA and, ultimately, our ability to
commercialize our product candidates and generate product revenues. In addition,
we anticipate that our clinical trials will involve only a small patient
population. Accordingly, the results of such trials may not be indicative
of
future results over a larger patient population.
Physicians
and patients may not accept and use our drugs.
Even
if
the FDA approves our product candidates, physicians and patients may not
accept
and use them. Acceptance and use of our product will depend upon a number
of
factors including:
· |
perceptions
by members of the health care community, including physicians,
about the
safety and effectiveness of our
drugs;
|
· |
cost-effectiveness
of our product relative to competing
products;
|
· |
availability
of reimbursement for our products from government or other healthcare
payers; and
|
· |
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
|
Because
we expect sales of our current product candidates, if approved, to generate
substantially all of our product revenues for the foreseeable future, the
failure of any of these drugs to find market acceptance would harm our business
and could require us to seek additional financing.
Our
drug-development program depends upon third-party researchers who are outside
our control.
We
currently are collaborating with several third-party researchers, for the
development of our product candidates. Accordingly, the successful development
of our product candidates will depend on the performance of these third parties.
These collaborators will not be our employees, however, and we cannot control
the amount or timing of resources that they will devote to our programs.
Our
collaborators may not assign as great a priority to our programs or pursue
them
as diligently as we would if we were undertaking such programs ourselves.
If
outside collaborators fail to devote sufficient time and resources to our
drug-development programs, or if their performance is substandard, the approval
of our FDA applications, if any, and our introduction of new drugs, if any,
will
be delayed. These collaborators may also have relationships with other
commercial entities, some of whom may compete with us. If our collaborators
assist our competitors at our expense, our competitive position would be
harmed.
20
We
rely exclusively on third parties to formulate and manufacture our product
candidates.
We
have
no experience in drug formulation or manufacturing and do not intend to
establish our own manufacturing facilities. We lack the resources and expertise
to formulate or manufacture our own product candidates. We intend to contract
with one or more manufacturers to manufacture, supply, store and distribute
drug
supplies for our clinical trials. If
any of
our product candidates receive FDA approval, we will rely on one or more
third-party contractors to manufacture our drugs. Our anticipated future
reliance on a limited number of third-party manufacturers, exposes us to
the
following risks:
· |
We
may be unable to identify manufacturers on acceptable terms or
at all
because the number of potential manufacturers is limited and the
FDA must
approve any replacement contractor. This approval would require
new
testing and compliance inspections. In addition, a new manufacturer
would
have to be educated in, or develop substantially equivalent processes
for,
production of our products after receipt of FDA approval, if
any.
|
· |
Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
needs
and commercial needs, if any.
|
· |
Our
future contract manufacturers may not perform as agreed or may
not remain
in the contract manufacturing business for the time required to
supply our
clinical trials or to successfully produce, store and distribute
our
products.
|
· |
Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA, the Drug Enforcement Agency, and corresponding state agencies
to
ensure strict compliance with good manufacturing practice and other
government regulations and corresponding foreign standards. We
do not have
control over third-party manufacturers’ compliance with these regulations
and standards.
|
· |
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share,
the
intellectual property rights to the
innovation.
|
We
have no experience selling, marketing or distributing products and no internal
capability to do so.
We
currently have no sales, marketing or distribution capabilities. We do not
anticipate having the resources in the foreseeable future to allocate to
the
sales and marketing of our proposed products. Our future success depends,
in
part, on our ability to enter into and maintain such collaborative
relationships, the collaborator’s strategic interest in the products under
development and such collaborator’s ability to successfully market and sell any
such products. We intend to pursue collaborative arrangements regarding the
sales and marketing of our products, however, there can be no assurance that
we
will be able to establish or maintain such collaborative arrangements, or
if
able to do so, that they will have effective sales forces. To the extent
that we
decide not to, or are unable to, enter into collaborative arrangements with
respect to the sales and marketing of our proposed products, significant
capital
expenditures, management resources and time will be required to establish
and
develop an in-house marketing and sales force with technical expertise. There
can also be no assurance that we will be able to establish or maintain
relationships with third party collaborators or develop in-house sales and
distribution capabilities. To the extent that we depend on third parties
for
marketing and distribution, any revenues we receive will depend upon the
efforts
of such third parties, and there can be no assurance that such efforts will
be
successful. In addition, there can also be no assurance that we will be able
to
market and sell our product in the United States or overseas.
21
If
we cannot compete successfully for market share against other drug companies,
we
may not achieve sufficient product revenues and our business will
suffer.
The
market for our product candidates is characterized by intense competition
and
rapid technological advances. If our product candidates receive FDA approval,
they will compete with a number of existing and future drugs and therapies
developed, manufactured and marketed by others. Existing or future competing
products may provide greater therapeutic convenience or clinical or other
benefits for a specific indication than our products, or may offer comparable
performance at a lower cost. If our products fail to capture and maintain
market
share, we may not achieve sufficient product revenues and our business will
suffer.
We
will
compete against fully integrated pharmaceutical companies and smaller companies
that are collaborating with larger pharmaceutical companies, academic
institutions, government agencies and other public and private research
organizations. Many of these competitors have product candidates that will
compete with ours already approved or in development. In addition, many of
these
competitors, either alone or together with their collaborative partners,
operate
larger research and development programs and have substantially greater
financial resources than we do, as well as significantly greater experience
in:
· |
developing
drugs;
|
· |
undertaking
nonclinical testing and human clinical
trials;
|
· |
obtaining
FDA and other regulatory approvals of
drugs;
|
· |
formulating
and manufacturing drugs; and
|
· |
launching,
marketing and selling drugs.
|
Developments
by competitors may render our products or technologies obsolete or
non-competitive.
Many
of
the organizations competing with us have substantially greater capital
resources, larger research and development staffs and facilities, longer
drug
development history in obtaining regulatory approvals and greater manufacturing
and marketing capabilities than we do. These organizations also compete with
us
to attract qualified personnel, parties for acquisitions, joint ventures
or
other collaborations.
If
we fail to adequately protect or enforce our intellectual property rights
or
secure rights to patents of others, the value of our intellectual property
rights would diminish.
Our
success, competitive position and future revenues will depend in part on
our
ability and the abilities of our licensors to obtain and maintain patent
protection for our products, methods, processes and other technologies, to
preserve our trade secrets, to prevent third parties from infringing on our
proprietary rights and to operate without infringing the proprietary rights
of
third parties.
22
We
currently do not directly own the rights to any issued patents. We license
the
exclusive rights to a total of four issued patents relating to our current
product candidates, which expire from 2013 to 2022. See “Business – Intellectual
Property and License Agreements.”.
However,
with regard to the patents covered by our license agreements and any future
patents issued to which we will have rights, we cannot predict:
· |
the
degree and range of protection any patents will afford us against
competitors including whether third parties will find ways to invalidate
or otherwise circumvent our
patents;
|
· |
if
and when patents will issue;
|
· |
whether
or not others will obtain patents claiming aspects similar to those
covered by our patents and patent applications;
or
|
· |
whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or
lose.
|
Our
success also depends upon the skills, knowledge and experience of our scientific
and technical personnel, our consultants and advisors as well as our licensors
and contractors. To help protect our proprietary know-how and our inventions
for
which patents may be unobtainable or difficult to obtain, we rely on trade
secret protection and confidentiality agreements. To this end, we require
all of
our employees, consultants, advisors and contractors to enter into agreements
which prohibit the disclosure of confidential information and, where applicable,
require disclosure and assignment to us of the ideas, developments, discoveries
and inventions important to our business. These agreements may not provide
adequate protection for our trade secrets, know-how or other proprietary
information in the event of any unauthorized use or disclosure or the lawful
development by others of such information. If any of our trade secrets, know-how
or other proprietary information is disclosed, the value of our trade secrets,
know-how and other proprietary rights would be significantly impaired and
our
business and competitive position would suffer.
If
we infringe the rights of third parties we could be prevented from selling
products, forced to pay damages, and defend against litigation.
Our
business is substantially dependent on the intellectual property on which
our
product candidates are based. To date, we have not received any threats or
claims that we may be infringing on another’s patents or other intellectual
property rights. If our products, methods, processes and other technologies
infringe the proprietary rights of other parties, we could incur substantial
costs and we may have to:
· |
obtain
licenses, which may not be available on commercially reasonable
terms, if
at all;
|
· |
redesign
our products or processes to avoid
infringement;
|
· |
stop
using the subject matter claimed in the patents held by
others;
|
· |
pay
damages; or
|
· |
defend
litigation or administrative proceedings which may be costly whether
we
win or lose, and which could result in a substantial diversion
of our
valuable management resources.
|
23
Our
ability to generate product revenues will be diminished if our drugs sell
for
inadequate prices or patients are unable to obtain adequate levels of
reimbursement.
Our
ability to commercialize our drugs, alone or with collaborators, will depend
in
part on the extent to which reimbursement will be available from:
· |
government
and health administration
authorities;
|
· |
private
health maintenance organizations and health insurers;
and
|
· |
other
healthcare payers.
|
Significant
uncertainty exists as to the reimbursement status of newly approved healthcare
products. Healthcare payers, including Medicare, are challenging the prices
charged for medical products and services. Government and other healthcare
payers increasingly attempt to contain healthcare costs by limiting both
coverage and the level of reimbursement for drugs. Even if our product
candidates are approved by the FDA, insurance coverage may not be available,
and
reimbursement levels may be inadequate, to cover our drugs. If government
and
other healthcare payers do not provide adequate coverage and reimbursement
levels for any of our products, once approved, market acceptance of our products
could be reduced.
We
may not successfully manage our growth.
Our
success will depend upon the expansion of our operations and the effective
management of our growth, which will place a significant strain on our
management and on our administrative, operational and financial resources.
To
manage this growth, we must expand our facilities, augment our operational,
financial and management systems and hire and train additional qualified
personnel. If we are unable to manage our growth effectively, our business
may
suffer.
If
we are unable to hire additional qualified personnel, our ability to grow
our
business may be harmed.
We
will
need to hire additional qualified personnel with expertise in nonclinical
testing, clinical research and testing, government regulation, formulation
and
manufacturing and sales and marketing. We compete for qualified individuals
with
numerous biopharmaceutical companies, universities and other research
institutions. Competition for such individuals is intense, and we cannot
be
certain that our search for such personnel will be successful. Attracting
and
retaining qualified personnel will be critical to our success.
We
may incur substantial liabilities and may be required to limit commercialization
of our products in response to product liability lawsuits.
The
testing and marketing of medical products entail an inherent risk of product
liability. If we cannot successfully defend ourselves against product liability
claims, we may incur substantial liabilities or be required to limit
commercialization of our products. We currently carry clinical trial insurance
in an amount up to $5,000,000, which may be inadequate to protect against
potential product liability claims or may inhibit the commercialization of
pharmaceutical products we develop, alone or with corporate collaborators.
Although we intend to maintain clinical trial insurance during any clinical
trials, this may be inadequate to protect us against any potential claims.
Even
if our agreements with any future corporate collaborators entitle us to
indemnification against losses, such indemnification may not be available
or
adequate should any claim arise.
24
We
are controlled by current officers, directors and principal
stockholders.
Our
directors, executive officers and principal stockholders beneficially own
approximately 27 percent of our outstanding voting stock and, including shares
underlying outstanding options and warrants. Accordingly, these persons and
their respective affiliates will have the ability to exert substantial influence
over the election of our Board of Directors and the outcome of issues submitted
to our stockholders.
Risks
Related to Our Securities
Our
stock price is, and we expect it to remain, volatile, which could limit
investors’ ability to sell stock at a profit.
During
the last two fiscal years, our stock price has traded at a low of $0.09 in
the
fourth quarter of 2007 to a high of $1.64 in the first quarter of 2006. The
volatile price of our stock makes it difficult for investors to predict the
value of their investment, to sell shares at a profit at any given time,
or to
plan purchases and sales in advance. A variety of factors may affect the
market
price of our common stock. These include, but are not limited to:
· |
publicity
regarding actual or potential clinical results relating to products
under
development by our competitors or
us;
|
· |
delay
or failure in initiating, completing or analyzing nonclinical or
clinical
trials or the unsatisfactory design or results of these
trials;
|
· |
achievement
or rejection of regulatory approvals by our competitors or
us;
|
· |
announcements
of technological innovations or new commercial products by our
competitors
or us;
|
· |
developments
concerning proprietary rights, including
patents;
|
· |
developments
concerning our collaborations;
|
· |
regulatory
developments in the United States and foreign
countries;
|
· |
economic
or other crises and other external factors;
|
· |
period-to-period
fluctuations in our revenues and other results of
operations;
|
· |
changes
in financial estimates by securities analysts;
and
|
· |
sales
of our common stock.
|
We
will
not be able to control many of these factors, and we believe that
period-to-period comparisons of our financial results will not necessarily
be
indicative of our future performance.
In
addition, the stock market in general, and the market for biotechnology
companies in particular, has experienced extreme price and volume fluctuations
that may have been unrelated or disproportionate to the operating performance
of
individual companies. These broad market and industry factors may seriously
harm
the market price of our common stock, regardless of our operating
performance.
25
We
have delisted
from the American Stock Exchange.
As
a
result of our delisting,
the
liquidity of our common stock may be reduced, not only in terms of the number
of
shares that can be bought and sold at a given price, but also through delays
in
the timing of transactions and reduction in security analysts’ and the media’s
coverage of us. This may result in lower prices for our common stock than
might
otherwise be obtained and could also result in a larger spread between the
bid
and asked prices for our common stock.
We
have never paid dividends.
We
have
never paid dividends on our common stock and do not anticipate paying any
dividends for the foreseeable future. You should not rely on an investment
in
our stock if you require dividend income. Further, you will only realize
income
on an investment in our stock in the event you sell or otherwise dispose
of your
shares at a price higher than the price you paid for your shares. Such a
gain
would result only from an increase in the market price of our common stock,
which is uncertain and unpredictable.
26
ITEM
2. LEGAL PROCEEDINGS
Swiss
Pharma Contract LTD (“Swiss Pharma”), a clinical site that the Company used in
one of its obesity trials, gave notice to the Company that Swiss Pharma believes
it is entitled to receive an additional payment of $322,776 for services
in
connection with that clinical trial. While the contract between the Company
and
Swiss Pharma provides for additional payments if certain conditions are met,
Swiss Parma has not specified which conditions they believe have been achieved
and the Company does not believe that Swiss Pharma is entitled to additional
payments and has not accrued any of these costs as of December 31, 2007.
The
contract between the Company and Swiss Pharma provides for arbitration in
the
event of a dispute, such as this claim for an additional payment. Swiss Pharma
has filed for arbitration. As the Company does not believe that Swiss Pharma
is
entitled to additional payments, it intends to defend its position in
arbitration. The arbitration process is currently in its initial
stage.
ITEM
3. DESCRIPTION OF PROPERTY
Our
executive offices are located at 810 Seventh Avenue, 4th Floor, New York,
New
York 10019. We currently occupy this space pursuant to a written lease that
expires on September 30, 2008 under which we pay rent of approximately $11,800
per month.
We
believe that our existing facilities are adequate to meet our current
requirements. We do not own any real property.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
We
held
our Annual Meeting of Stockholders at the American Stock Exchange, 86 Trinity
Place, New York, New York on May 24, 2007. The stockholders took the following
actions:
(i)
The
stockholders elected seven directors to serve until the next Annual Meeting
of
Stockholders. The stockholders present in person or by proxy cast the following
numbers of votes in connection with the election of directors, resulting
in the
election of all nominees:
Nominee
|
Votes For
|
|
Votes Withheld
|
||||
Douglas
Abel
|
35,536,892
|
65,132
|
|||||
Neil
Herskowitz
|
35,376,093
|
225,931
|
|||||
Malcolm
Hoenlein
|
35,518,495
|
83,529
|
|||||
Timothy
McInerney
|
35,538,692
|
63,332
|
|||||
Joan
Pons Gimbert
|
35,154,378
|
447,646
|
|||||
Richard
I. Steinhart
|
35,529,736
|
72,288
|
|||||
Michael
Weiser
|
34,493,245
|
1,108,779
|
(ii)
The
stockholders ratified the amendment to our 2003 Stock Option Plan increasing
the
number of shares available for issuance thereunder from 7,400,000 to 10,400,000.
34,440,971 votes were cast for the proposal; 1,107,853 votes were cast against
the proposal, shares representing 53,200 votes abstained; and there were
no
broker non-votes.
(iii)
The
stockholders ratified the appointment of J.H. Cohn LLP as our independent
registered public accounting firm for fiscal 2007. 35,519,099 votes were
cast
for the proposal; 8,205 votes were cast against the proposal, shares
representing 74,720 votes abstained; and there were no broker
non-votes.
27
PART
II
ITEM
5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
Market
for Common Stock
Our
common stock traded on
the
American Stock Exchange “AMEX”under the symbol “MHA” during the years ended
December 31, 2006 and 2007. The
following table lists the high and low price for our common stock as quoted,
in
U.S. dollars, on the American Stock Exchange during each quarter within the
last
two fiscal years:
Price
Range
|
|||||||||||||
2007
|
2006
|
||||||||||||
Quarter
Ended
|
High
|
Low
|
High
|
Low
|
|||||||||
March
31
|
$
|
0.96
|
$
|
0.70
|
$
|
1.640
|
$
|
1.160
|
|||||
June
30
|
1.10
|
0.69
|
1.360
|
0.075
|
|||||||||
September
30
|
0.78
|
0.22
|
0.880
|
0.620
|
|||||||||
December
31
|
0.23
|
0.09
|
0.920
|
0.620
|
On
March
26, 2008 our common stock was voluntarily delisted from the AMEX and began
trading on the Over the Counter Bulletin Board (“OCTBB”) under the symbol
“MHAN”.
Record
Holders
The
number of holders of record of our common stock as of March17, 2008 was
460.
Dividends
We
have
not paid or declared any dividends on our common stock and we do not anticipate
paying dividends on our common stock in the foreseeable future.
Stock
Repurchases
We
did
not make any repurchases of our common stock during 2007.
Securities
authorized for issuance under equity compensation plans.
See
Note
6 to Consolidated Financial Statements.
28
ITEM 6. |
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
|
Overview
We
were
incorporated in Delaware in 1993 under the name “Atlantic Pharmaceuticals, Inc.”
and, in March 2000, we changed our name to “Atlantic Technology Ventures, Inc.”
In 2003, we completed a “reverse acquisition” of privately held “Manhattan
Research Development, Inc”. In connection with this transaction, we also changed
our name to “Manhattan Pharmaceuticals, Inc.” From an accounting perspective,
the accounting acquirer is considered to be Manhattan Research Development,
Inc.
and accordingly, the historical financial statements are those of Manhattan
Research Development, Inc.
During
2005 we merged with Tarpan Therapeutics, Inc. (“Tarpan”). Tarpan was a privately
held New York based biopharmaceutical company developing dermatological
therapeutics. Through the merger, we acquired Tarpan’s primary product
candidate, Topical PTH (1-34) for the treatment of psoriasis. In consideration
for their shares of Tarpan’s capital stock, the stockholders of Tarpan received
an aggregate of approximately 10,731,000 shares of our common stock,
representing approximately 20% of our then outstanding common shares. This
transaction was accounted for as a purchase of Tarpan by the
Company.
We
are a
clinical-stage specialty pharmaceutical company focused on developing and
commercializing innovative pharmaceutical therapies for underserved patient
populations. We aim to acquire rights to these technologies by licensing or
otherwise acquiring an ownership interest, funding their research and
development and eventually either bringing the technologies to market or
out-licensing. We currently have four product candidates in development: Hedrin,
a novel, non-insecticide treatment of pediculitis (head lice); topical PTH
(1-34) for the treatment of psoriasis; Altoderm for the treatment of pruritis
(itch) associated with dermatologic conditions including atopin dermatitis;
and
Altolyn for the treatment of mastocystosis. We have not received regulatory
approval for, or generated commercial revenues from marketing or selling any
drugs.
You
should read the following discussion of our results of operations and financial
condition in conjunction with the consolidated financial statements and notes
thereto appearing elsewhere in this Form 10-K. This discussion includes
“forward-looking” statements that reflect our current views with respect to
future events and financial performance. We use words such as we “expect,”
“anticipate,” “believe,” and “intend” and similar expressions to identify
forward-looking statements. Investors should be aware that actual results may
differ materially from our expressed expectations because of risks and
uncertainties inherent in future events, particularly those risks identified
under the heading “Risk Factors” following Item 1 in this Annual Report, and
should not unduly rely on these forward looking statements. All share and per
share information in this discussion has been adjusted for the 1-for-5
combination of our common stock effected on September 25, 2003.
Results
Of Operations
2007
versus 2006
During
each of the years ended December 31, 2007 and 2006, we had no revenues, and
are
considered a development stage company. We do not expect to have revenues
relating to our products prior to December 31, 2008.
29
|
Years ended December 31,
|
||||||||||||
2007
|
2006
|
Increase
(decrease) |
% Increase
(decrease) |
||||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
539,000
|
$
|
529,000
|
$
|
10,000
|
1.89
|
%
|
|||||
In-license,
milestone and related fees
|
2,245,000
|
250,000
|
1,995,000
|
798.00
|
%
|
||||||||
Other
research and development expenses
|
5,752,000
|
5,394,000
|
358,000
|
6.64
|
%
|
||||||||
Total
research and development expenses
|
8,536,000
|
6,173,000
|
2,363,000
|
38.28
|
%
|
||||||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
902,000
|
1,147,000
|
(245,000
|
)
|
-21.36
|
%
|
|||||||
Other
general and administrative expenses
|
2,706,000
|
2,680,000
|
26,000
|
0.97
|
%
|
||||||||
Total
general and administrative expenses
|
3,608,000
|
3,827,000
|
(219,000
|
)
|
-5.72
|
%
|
|||||||
Other
income
|
112,000
|
305,000
|
(193,000
|
)
|
-63.28
|
%
|
|||||||
Net
loss
|
$
|
12,032,000
|
$
|
9,695,000
|
$
|
2,337,000
|
24.11
|
%
|
For
the
year ended December 31, 2007 research and development expense was $8,536,000
as
compared to $6,173,000 for the year ended December 31, 2006. This increase
of
$2,363,000, or 38.3%, is primarily comprised of an increase in in-license,
milestone and related fees of $1,995,000, an increase in other research and
development expenses of $358,000 and an increase in stock based compensation
of
$10,000.
For
the
year ended December 31, 2007 general and administrative expense was $3,608,000
as compared to $3,827,000 for the year ended December 31, 2006. This decrease
of
$219,000, or 5.7%, is primarily comprised of a decrease in stock based
compensation of $245,000 partially offset by an increase in other general and
administrative expense of $26,000.
For
the
year ended December 31, 2007 other income was $112,000 as compared to $305,000
for the year ended December 31, 2006. This decrease of $193,000, or 63.3%,
is
primarily due to a decrease in interest income which resulted from lower average
balances in interest bearing and short-term investment accounts.
Net
loss
for the year ended December 31, 2007 was $12,032,000 as compared to $9,695,000
for the year ended December 31, 2006. This increase of $2,337,000, or 24.11%,
is
primarily due to an increase in in-license, milestone and related fees of
$1,995,000, an increase in other research and development expenses of $358,000
and a decrease of $193,000 in other income partially offset by a decrease in
stock based compensation of $235,000.
Liquidity
and Capital Resources
From
inception to December 31, 2007, we incurred a deficit during the development
stage of $54,999,000 primarily as a result of our net losses, and we expect
to
continue to incur additional losses through at least December 31, 2008 and
for
the foreseeable future. These losses have been incurred through a combination
of
research and development activities related to the various technologies under
our control and expenses supporting those activities.
We
have
financed our operations since inception primarily through equity financing.
During the year ended December 31, 2007, we had a net decrease in cash and
cash
equivalents of $2,379,000. This decrease resulted largely from net cash used
in
operating activities of $10,230,000 partially offset by net cash provided by
financing activities of $7,859,000. Total liquid resources as of December 31,
2007 were $650,000 compared to $3,029,000.
30
Our
current liabilities as of December 31, 2007 were $1,872,000 compared to
$1,943,000 at December 31, 2006, a decrease of $71,000. As of December 31,
2007,
we had working capital deficit of $1,006,000 compared to working capital of
$1,350,000 at December 31, 2006.
In
February 2008, we completed a joint venture transaction. We received net
proceeds of approximately $2.0 million from this joint venture
transaction.
Our
available working capital and capital requirements will depend upon numerous
factors, including progress of our research and development programs, our
progress in and the cost of ongoing and planned nonclinical and clinical
testing, the timing and cost of obtaining regulatory approvals, the cost of
filing, prosecuting, defending, and enforcing patent claims and other
intellectual property rights, in-licensing activities, competing technological
and market developments, changes in our existing collaborative and licensing
relationships, the resources that we devote to developing manufacturing and
commercializing capabilities, the status of our competitors, our ability to
establish collaborative arrangements with other organizations and our need
to
purchase additional capital equipment.
Our
continued operations will depend on whether we are able to raise additional
funds through various potential sources, such as equity and debt financing,
other collaborative agreements, strategic alliances, and our ability to realize
the full potential of our technology in development. Such additional funds
may
not become available on acceptable terms and there can be no assurance
that any additional funding that we do obtain will be sufficient to meet our
needs in the long term. Through
December 31, 2007, a significant portion of our financing has been through
private placements of common stock and warrants. Unless our operations generate
significant revenues and cash flows from operating activities, we will continue
to fund operations from cash on hand and through the similar sources of capital
previously described. We can give no assurances that any additional capital
that
we are able to obtain will be sufficient to meet our needs. We
believe that we will continue to incur net losses and negative cash flows from
operating activities for the foreseeable future. Based on the resources
available to us at December 31, 2007 and the net proceeds from the February
2008
joint venture transaction, management believes we do not have sufficient capital
to fund our operations through the end of 2008. Management believes that we
will
need additional equity or debt financing or will need to generate revenues
through licensing our products or entering into strategic alliances during
2008
to be able to sustain our operations during 2008 and we will need additional
financing thereafter until we can achieve profitability, if ever.
We
have
reported net losses of $12,032,000 and $9,695,000 for the years ended December
31, 2007 and 2006, respectively. The net loss attributable to common shares
from
date of inception, including preferred stock dividends, August 6, 2001 to
December 31, 2007, amounts to $54,999,000. Management believes that we will
continue to incur net losses through at least December 31, 2008.
Joint
Venture Agreement
In
February 2008, the Company and Nordic Biotech Advisors ApS through its
investment fund Nordic Biotech Venture Fund II K/S (“Nordic”) entered into a
50/50 joint venture agreement (the “Hedrin JV”) to develop and commercialize the
Company's North American rights (under license) to its Hedrin product.
Pursuant
to the Hedrin JV Agreement, Nordic formed a new Danish limited partnership
(the
"Hedrin JV") and provided it with initial funding of $2.5 million. The Company
assigned and transferred its North American rights in Hedrin to the Hedrin
JV in
return for a $2.0 million cash payment and equity in the Hedrin JV representing
50% of the nominal equity interests in the Hedrin JV .
31
Should
the Hedrin JV be successful in achieving a payment milestone, namely that by
September 30, 2008, the FDA determines to treat Hedrin as a medical device,
Nordic will purchase an additional $2.5 million of equity in the Hedrin JV,
whereupon the Hedrin JV will pay the Company an additional $1.5 million in
cash
and issue to the Company an additional $2.5 million in equity in the Hedrin
JV,
thereby maintaining the Company’s 50% ownership interest in the Hedrin
JV.
The
Hedrin JV will be responsible for the development and commercialization of
Hedrin for the North American market and all associated costs including clinical
trials, if required, regulatory costs, patent costs, and future milestone
payments owed to T&R, the licensor of Hedrin.
The
Hedrin JV will engage the Company to provide management services to the Limited
Partnership in exchange for an annualized management fee, which for 2008, on
an
annualized basis, is $527,000.
Nordic
paid to the Company a non-refundable fee of $150,000 at the closing for the
right to receive a warrant covering 7.1 million shares of the Company’s common
stock, exercisable for $0.14 per share. The warrant is issuable 90 days from
closing, provided Nordic has not exercised all or a part of its put, as
described below. The per share exercise price of the warrant was based on the
volume weighted average price of the Company’s common stock for the period prior
to the signing of the Hedrin JV Agreement.
Nordic
has an option to put all or a portion of its equity interest in the Hedrin
JV to
the Company in exchange for the Company’s common stock. The shares of the
Company’s common stock to be issued upon exercise of the put will be calculated
by multiplying the percentage of Nordic’s equity in the Hedrin JV p that Nordic
decides to put to the Company multiplied by the dollar amount of Nordic’s
investment in Limited Partnership divided by $0.14, as adjusted from time to
time. The put option is exercisable immediately and expires at the earlier
of
ten years or when Nordic’s distributions from the Limited Hedrin JV exceed five
times the amount Nordic invested in the Hedrin JV.
The
Company has an option to call all or a portion of Nordic’s equity interest in
the Hedrin JV in exchange for the Company’s common stock. The Company cannot
begin to exercise its call until the price of the Company’s common stock has
closed at or above $1.40 per share for 30 consecutive trading days. During
the
first 30 consecutive trading day period in which the Company’s common stock
closes at or above $1.40 per share the Company can exercise up to 25% of its
call option. During the second 30 consecutive trading day period in which the
Company’s common stock closes at or above $1.40 per share the Company can
exercise up to 50% of its call option on a cumulative basis. During the third
30
consecutive trading day period in which the Company’s common stock closes at or
above $1.40 per share the Company can exercise up to 75% of its call option
on a
cumulative basis. During the fourth 30 consecutive trading day period in which
the Company’s common stock closes at or above $1.40 per share the Company can
exercise up to 100% of its call option on a cumulative basis. The shares of
the
Company’s common stock to be issued upon exercise of the call will be calculated
by multiplying the percentage of Nordic’s equity in the Limited Partnership that
the Company calls, as described above, multiplied by the dollar amount of
Nordic’s investment in the Hedrin JV divided by $0.14. Nordic can refuse the
Company’s call by either paying the Company up to $1.5 million or forfeiting all
or a portion of their put, calculated on a pro rata basis for the percentage
of
the Nordic equity interest called by the Company.
32
The
Hedrin JV 's Board will consist of 4 members, 2 appointed by the Company and
2
appointed by Nordic. Nordic has the right to appoint one of the directors as
chairman of the Board. The chairman has certain tie breaking powers. In the
event that the payment milestone described above is not achieved by June 30,
2008, then the Hedrin JV 's Board will increase to 5 members, 2 appointed by
the
Company and 3 appointed by Nordic.
After
the
closing, at Nordic's request, the Company will nominate a person identified
by
Nordic to serve on the Company’s Board of Directors.
The
Company will grant Nordic registration rights for the shares to be issued upon
exercise of the warrant, the put or the call. The Company is required to file
an
initial registration statement within 10 calendar days of filing its Form 10-K
for the year ended December 31, 2007. The Company is required to file additional
registration statements, if required, within 45 days of the date the Company
first knows that such additional registration statement was required. The
Company is required to use commercially reasonable efforts to cause the
registration statement to be declared effective by the Securities and Exchange
Commission (“SEC”) within 105 calendar days from the filing date. If the Company
fails to file a registration statement on time or if a registration statement
is
not declared effective by the SEC within 105 days of filing the Company will
be
required to pay to Nordic, or its assigns, an amount in cash, as partial
liquidated damages, equal to 0.5% per month of the amount invested in the Hedrin
JV by Nordic until the registration statement is declared effective by the
SEC.
In no event shall the aggregate amount payable by the Company exceed 9% of
the
amount invested in the Hedrin JV by Nordic.
The
profits of the Hedrin JV will be shared by the Company and Nordic in accordance
with their respective equity interests in Limited Partnership, which are
currently 50% to each, except that Nordic will get a minimum guaranteed return
from the Hedrin JV equal to 5% on Hedrin sales, as adjusted for any change
in
Nordic’s equity interest in the Limited Partnership. If the Hedrin JV realizes a
profit equal to or greater than a 10% royalty on Hedrin sales, then profits
will
be shared by the Company and Nordic in accordance with their respective equity
interests in the Limited Partnership. However, in the event of a liquidation
of
the Limited Partnership, Nordic’s distribution in liquidation will be at least
equal to the amount Nordic invested in the Hedrin JV ($5 million if the payment
milestone described above is met, $2.5 million if it is not met) plus 10% per
year, less the cumulative distributions received by Nordic from the Hedrin
JV.
Further, in no event shall Nordic’s distribution in liquidation be greater than
assets available for distribution in liquidation.
American
Stock Exchange
In
September 2007, we received notice from the staff of AMEX, indicating that
we
were not in compliance with certain continued listing standards set forth in
the
American Stock Exchange Company guide. Specifically, the American Stock Exchange
notice cited our failure to comply, as of June 30, 2007, with section
1003(a)(ii) of the AMEX Company Guide as we had less than $4,000,000 of
stockholders’ equity and had losses from continuing operations and /or net
losses in three or four of our most recent fiscal years and with section
1003(a)(iii) which requires us to maintain $6,000,000 of stockholders’ equity if
we have experienced losses from continuing operations and /or net losses in
its
five most recent fiscal years.
In
order
to maintain our AMEX listing, we were required to submit a plan to AMEX advising
the exchange of the actions we have taken, or will take, that would bring us
into compliance with all the continued listing standards by April 16, 2008.
We
submitted such a plan in October 2007. If we are not in compliance with the
continued listing standards at the end of the plan period, or if we do not
make
progress consistent with the plan during the period, AMEX staff may initiate
delisting proceedings.
33
Under
the
terms of the Joint Venture Agreement, the number of potentially issuable shares
represented by the put and call features of the Hedrin agreement, and the
warrant issuable to Nordic, would exceed 19.9% of our total outstanding shares
and would be issued at a price below the greater of book or market value. As
a
result, under AMEX regulations, we would not have been able to complete the
transaction without first receiving either stockholder approval for the
transaction, or a formal “financial viability” exception from AMEX’s stockholder
approval requirement. We estimated that obtaining stockholder approval to comply
with AMEX regulations would take a minimum of 45 days to complete. We discussed
the financial viability exception with AMEX for several weeks and had neither
received the exception nor been denied the exception. We determined that our
financial condition required us to complete the transaction immediately, and
that the Company’s financial viability depended on its completion of the
transaction without further delay.
Accordingly,
to maintain the Company’s financial viability, on February 28, 2008 we announced
that we had formally notified AMEX that we intend to voluntarily delist our
common stock from AMEX. The delisting became effective on March 26,
2008.
Our
common stock now trades on the Over the Counter Bulletin Board (“OCTBB”) under
the symbol “MHAN”. We intend to maintain corporate governance, disclosure and
reporting procedures consistent with applicable law.
Commitments
General
We
often
contract with third parties to facilitate, coordinate and perform agreed upon
research and development of our product candidates. To ensure that research
and
development costs are expensed as incurred, we record monthly accruals for
clinical trials and nonclinical testing costs based on the work performed under
the contracts.
These
contracts typically call for the payment of fees for services at the initiation
of the contract and/or upon the achievement of certain milestones. This method
of payment often does not match the related expense recognition resulting in
either a prepayment, when the amounts paid are greater than the related research
and development costs recognized, or an accrued liability, when the amounts
paid
are less than the related research and development costs
recognized.
Expenses
associated with the clinical trials in common obesity and morbid obesity, which
were concluded during 2007, were recognized on this activity based basis. At
December 31, 2007 we recognized accrued expenses of $74,000 related to these
clinical trials. There are no remaining financial commitments for these clinical
trials.
The
Company is developing Topical PTH (1-34) as a topical treatment for psoriasis.
Expenses associated with the manufacture of clinical and non-clinical supplies
of Topical PTH (1-34) are recognized on this activity based method. At December
31, 2007 we recognized prepaid expense of $30,000 related to the manufacture
of
Topical PTH (1-34). The remaining financial commitment related to the
manufacture of Topical PTH (1-34) is negligible.
During
2007 we entered into an agreement with Therapeutics, Inc. for the conduct of
a
Phase 2a clinical trial of Topical PTH (1-34). The amount of the agreement
is
approximately $845,000. At December 31, 2007 we recognized research and
development expense of $483,000 related to the conduct of this clinical trial.
At December 31, 2007 we recognized prepaid expense of $19,000 related to this
clinical trial. The remaining financial commitment related to the conduct of
the
clinical trial is approximately $340,000. This clinical trial is expected to
conclude in the second quarter of 2008.
34
Swiss
Pharma Contract LTD (“Swiss Pharma”), a clinical site that the Company used in
one of its obesity trials, gave notice to the Company that Swiss Pharma believes
it is entitled to receive an additional payment of $322,776 for services in
connection with that clinical trial. While the contract between the Company
and
Swiss Pharma provides for additional payments if certain conditions are met,
Swiss Parma has not specified which conditions they believe have been achieved
and the Company does not believe that Swiss Pharma is entitled to additional
payments and has not accrued any of these costs as of December 31, 2007. The
contract between the Company and Swiss Pharma provides for arbitration in the
event of a dispute, such as this claim for an additional payment. Swiss Pharma
has filed for arbitration. As the Company does not believe that Swiss Pharma
is
entitled to additional payments, it intends to defend its position in
arbitration. The arbitration process is currently in its initial
stage.
In
February 2007, a former employee of the Company alleged an ownership interest
in
two of the Company’s provisional patent applications covering our discontinued
product development program for Oleoyl-estrone. Also, without articulating
precise legal claims, the former employee contends that the Company wrongfully
characterized the former employee’s separation from employment as a resignation
instead of a dismissal in an effort to harm the former employee’s immigration
sponsorship efforts, and, further, to wrongfully deprive the former employee
of
the former employee’s alleged rights in two of the Company’s provisional patent
applications. The former employee is seeking an unspecified amount in damages.
The Company refutes the former employee’s contentions and intends to vigorously
defend itself should the former employee file claims against the Company. There
have been no further developments with respect to these
contentions.
Development
Commitments
Hedrin
On
June
26, 2007, the Company entered into an exclusive license agreement for Hedrin
(the “Hedrin Agreement”) with T&R and Kerris, S.A. (“Kerris”). Pursuant to
the Hedrin Agreement, the Company has acquired an exclusive North American
license to certain patent rights and other intellectual property relating to
HedrinTM
a
non-insecticide product candidate for the treatment of pediculosis (head lice).
In addition, on June 26, 2007, the Company entered into a Supply Agreement
with
T&R pursuant to which T&R will be the Company’s exclusive supplier of
Hedrin product.
In
consideration for the license, the Company issued to T&R and Kerris
(jointly, the “Licensor”) a combined total of 150,000 shares of its common stock
valued at $120,000. In addition, the Company also made a cash payment of
$600,000 to the Licensor. These amounts are included in research and development
expense.
Further,
the Company agreed to make future milestone payments to T&R comprised of
various combinations of cash and common stock in respective aggregate amounts
of
$2,500,000 upon the achievement of various clinical and regulatory milestones
as
follows: $250,000 upon acceptance by the U. S. Food and Drug Administration
(“FDA”) of an Investigational New Drug application (“IND”); $1,000,000 upon the
achievement of a successful outcome of a Phase 3 clinical trial; $700,000 upon
the final approval of an NDA by the FDA; $300,000 upon the issuance of a U.S.
patent on Hedrin: and $250,000 upon receipt of marketing authorization in
Canada.
35
The
Company also agreed to pay royalties of 8% (or, under certain circumstances,
4%)
on net sales of licensed products. The Company’s exclusivity under the Hedrin
Agreement is subject to an annual minimum royalty payment of $1,000,000 (or,
under certain circumstances, $500,000) in each of the third through seventh
years following the first commercial sale of Hedrin. The Company may sublicense
its rights under the Hedrin Agreement with the consent of Licensor and the
proceeds resulting from such sublicenses will be shared with the Licensor.
Through
December 31, 2007, none of the milestones have been reached and sales have
not
commenced, therefore, we have not paid any such milestones or
royalties.
Pursuant
to the Supply Agreement, the Company has agreed that it and its sublicensees
will purchase their respective requirements of the Hedrin product from T&R
at agreed upon prices. Under certain circumstances where T&R is unable to
supply Hedrin product in accordance with the terms and conditions of the Supply
Agreement, the Company may obtain products from an alternative supplier subject
to certain conditions. The term of the Supply Agreement ends upon termination
of
the Hedrin Agreement.
Topical
PTH
(1-34)
Through
our April 2005 acquisition of Tarpan Therapeutics, Inc., we acquired a
Sublicense Agreement with IGI, Inc. dated April 14, 2004. Under the IGI
sublicense agreement we hold the exclusive, world-wide, royalty bearing
sublicense to develop and commercialize the licensed technology. Under the
terms
of the IGI sublicense agreement, we are responsible for the cost of the
nonclinical and clinical development of the project, including research and
development, manufacturing, laboratory and clinical testing and trials and
marketing of licensed products.
The
IGI
sublicense agreement requires us to make certain milestone payments as follows:
$300,000 payable upon the commencement of a Phase 2 clinical trial; $500,000
upon the commencement of a Phase 3 clinical trial; $1,500,000 upon the
acceptance of an NDA application by the FDA; $2,400,000 upon the approval of
an
NDA by the FDA; $500,000 upon the commencement of a Phase 3 clinical trial
for
an indication other than psoriasis; $1,500,000 upon the acceptance of and NDA
application for an indication other than psoriasis by the FDA; and $2,400,000
upon the approval of an NDA for an indication other than psoriasis by the
FDA.
During
2007, we achieved the milestone of the commencement of Phase 2 clinical trial.
As a result $300,000 became payable to IGI. This $300,000 is included in
research and development expense for the year ended December 31, 2007. Payment
was made to IGI in February 2008. At December 31, 2007 this $300,000 liability
is reflected in accounts payable.
In
addition, we are obligated to pay IGI, Inc. an annual royalty of 6% on annual
net sales up to $200,000,000. In any calendar year in which net sales exceed
$200,000,000, we are obligated to pay IGI, Inc. an annual royalty of 9% on
such
excess. Through December 31, 2007, sales have not commenced, therefore, we
have
not paid any such royalties.
IGI,
Inc.
may terminate the agreement (i) upon 60 days’ notice if we fail to make any
required milestone or royalty payments, or (ii) if we become bankrupt or if
a
petition in bankruptcy is filed, or if we are placed in the hands of a receiver
or trustee for the benefit of creditors. IGI, Inc. may terminate the agreement
upon 60 days’ written notice and an opportunity to cure in the event we commit a
material breach or default. Eighteen months from the date of the IGI sublicense
agreement, we may terminate the agreement in whole or as to any portion of
the
PTH patent rights upon 90 days’ notice to IGI, Inc.
36
Altoderm
On
April
3, 2007, the Company entered into a license agreement for “Altoderm” (the
“Altoderm Agreement”) with T&R. Pursuant to the Altoderm Agreement, the
Company acquired an exclusive North American license to certain patent rights
and other intellectual property relating to Altoderm, a topical skin lotion
product candidate with the active ingredient cromolyn sodium (also known as
sodium cromoglicate) for the treatment of atopic dermatitis. In accordance
with
the terms of the Altoderm Agreement, the Company issued 125,000 shares of its
common stock, valued at $112,500, and made a cash payment of $475,000 to T&R
upon the execution of the agreement. These amounts have been included in
research and development expense.
Further,
the Company agreed to make future milestone payments to T&R comprised of
various combinations of cash and common stock in respective aggregate amounts
of
$5,675,000 and 875,000 shares of our common stock upon the achievement of
various clinical and regulatory milestones. as follows: $450,000 upon acceptance
by the U. S. Food and Drug Administration (“FDA”) of an Investigational New Drug
application (“IND”); 125,000 shares of our common stock upon the first dosing of
a patient in the first Phase 2 clinical trial; 250,000 shares of our common
stock and $625,000 upon the first dosing of a patient in the first Phase 3
clinical trial; $1,000,000 upon the achievement of a successful outcome of
a
Phase 3 clinical trial; $1,100,000 upon the acceptance for filing of a New
Drug
Application (“NDA”) application by the FDA; 500,000 shares of our common stock
and $2,000,000 upon the final approval of an NDA by the FDA; and $500,000 upon
receipt of marketing authorization in Canada.
In
addition, we are obligated to pay T&R an annual royalty of 10% on annual net
sales of up to $100,000,000; 15% of the amount of annual net sales in excess
of
$100,000,000 and 20% of annual net sales in excess of $200,000,000. There is
a
minimum royalty of $1,000,000 per year. There is a one-time success fee of
$10,000,000 upon the achievement of of cumulative net sales of $100,000,000.
Through December 31, 2007, none of the milestones have been reached and sales
have not commenced, therefore, we have not paid any such milestones or
royalties.
Through
December 31, 2007, none of the milestones have been reached and sales have
not
commenced, therefore, we have not paid any such milestones or
royalties.
Altolyn
On
April
3, 2007, the Company and T&R also entered into a license agreement for
Altolyn (the “Altolyn Agreement”). Pursuant to the Altolyn Agreement, the
Company acquired an exclusive North American license to certain patent rights
and other intellectual property relating to Altolyn, an oral formulation product
candidate using cromolyn sodium for the treatment of mastocytosis, food
allergies, and inflammatory bowel disorder. In accordance with the terms of
the
Altolyn Agreement, the Company made a cash payment of $475,000 to T&R upon
the execution of the agreement. This amount is included in research and
development expense.
Further,
the Company agreed to make future milestone payments to T&R comprised of
various combinations of cash and common stock in respective aggregate amounts
of
$5,675,000 upon the achievement of various clinical and regulatory milestones.
as follows: $450,000 upon acceptance for filing by the FDA of an IND; $625,000
upon the first dosing of a patient in the first Phase 3 clinical trial;
$1,000,000 upon the achievement of a successful outcome of a Phase 3 clinical
trial; $1,100,000 upon the acceptance for filing of a New Drug Application
(“NDA”) application by the FDA; $2,000,000 upon the final approval of an NDA by
the FDA; and $500,000 upon receipt of marketing authorization in
Canada.
37
In
addition, we are obligated to pay T&R an annual royalty of 10% on annual net
sales of up to $100,000,000; 15% of the amount of annual net sales in excess
of
$100,000,000 and 20% of annual net sales in excess of $200,000,000. There is
a
minimum royalty of $1,000,000 per year. There is a one-time success fee of
$10,000,000 upon the achievement of cumulative net sales of
$100,000,000.
Through
December 31, 2007, none of the milestones have been reached and sales have
not
commenced, therefore, we have not paid any such milestones or
royalties.
Oleoyl-estrone
On
July
9, 2007, the Company announced the results of its two Phase 2a clinical trials
of oral OE. The results of both randomized, double-blind, placebo controlled
studies, one in common obesity and the other in morbid obesity, demonstrated
no
statistically or clinically meaningful placebo adjusted weight loss for any
of
the treatment arms evaluated. Based on these results, the Company discontinued
its Oleoyl-estrone programs in both common obesity and morbid
obesity.
Propofol
Lingual Spray
On
July
9, 2007, the Company announced that it is discontinued development of Propofol
Lingual Spray for pre-procedural sedation.
Research
and Development Projects
Hedrin
In
collaboration with Nordic and through the Hedrin JV we are developing Hedrin
for
the treatment of pediculosis (head lice). To date, Hedrin has been clinically
studied in 326 subjects and is currently marketed as a device in Western Europe
and as a pharmaceutical in the United Kingdom (U.K.).
In
a
randomized, controlled, equivalence clinical study conducted in Europe by
T&R, Hedrin was administered to 253 adult and child subjects with head louse
infestation. The study results, published in the British Medical Journal in
June
2005, demonstrated Hedrin’s equivalence when compared to the insecticide
treatment, phenothrin, the most widely used pediculicide in the U.K. In
addition, according to the same study, the Hedrin-treated subjects experienced
significantly less irritation (2%) than those treated with phenothrin
(9%).
An
additional clinical study published in the November 2007 issue of PLoS One,
an
international, peer-reviewed journal published by the Public Library of Science
(PLoS), demonstrated Hedrin’s superior efficacy compared to a U.K. formulation
of malathion, a widely used insecticide treatment in both Europe and North
America. In this randomized, controlled, assessor blinded, parallel group
clinical trial, 73 adult and child subjects with head lice infestations were
treated with Hedrin or malathion liquid. Using intent-to-treat analysis, Hedrin
achieved a statistically significant cure rate of 70% compared to 33% with
malathion liquid. Using the per-protocol analysis Hedrin achieved a highly
statistically significant cure rate of 77% compared to 35% with malathion.
In
Europe it has been widely documented that head lice had become resistant to
European formulations of malathion, and we believe this resistance had
influenced these study results. To date, there have been no reports of
resistance to U.S. formulations of malathion. Additionally, Hedrin treated
subjects experienced no irritant reactions, and Hedrin showed clinical
equivalence to malathion in its ability to inhibit egg hatching. Overall,
investigators and study subjects rated Hedrin as less odorous, easier to apply,
and easier to wash out, and 97% of Hedrin treated subjects stated they were
significantly more inclined to use the product again versus 31% of those using
malathion.
38
In
the
United States, Manhattan Pharmaceuticals is pursuing the development of Hedrin
as a medical device and has submitted a regulatory package to the FDA’s Center
for Devices and Radiological Health. The Company expects to be required to
complete at least one clinical trial with this product candidate.
To
date,
we have incurred $1,070,000 of project costs for the development of Hedrin.
All
of such costs were incurred during 2007.
Topical
PTH
(1-34).
We
are
developing Topical PTH (1-34) as a topical treatment for psoriasis. In August
2003, researchers, led by Michael Holick, Ph.D., MD, Professor of Medicine,
Physiology, and Biophysics at Boston University Medical Center, reported
positive results from a US Phase 1/2 clinical trial evaluating the safety and
efficacy of Topical PTH (1-34) as a topical treatment for psoriasis. This
double-blind, placebo controlled trial in 15 patients compared Topical PTH
(1-34) formulated in the Novasome® Technology versus the Novasome® vehicle
alone. Following 8 weeks of treatment, the topical application of Topical PTH
(1-34) resulted in complete clearing of the treated lesion in 60% of patients
and partial clearing in 85% of patients. Additionally, there was a statistically
significant improvement in the global severity score. Ten patients continued
into an open label extension study in which the Psoriasis Area and Severity
Index, or PASI, was measured; PASI improvement across all 10 patients achieved
statistically significant improvement compared to baseline. This study showed
Topical PTH (1-34) to be a safe and effective treatment for plaque psoriasis
with no patients experiencing any clinically significant adverse
events.
Due
to
the high response rate seen in patients in the initial trial with Topical PTH
(1-34) we believe that it may have an important clinical advantage over current
topical psoriasis treatments. A follow on physician IND Phase 2a trial involving
Topical PTH (1-34) was initiated in December 2005 under the auspices of Boston
University. In April 2006, we reported a delay in its planned Phase 2a clinical
study of Topical PTH (1-34) due to a formulation issue. We believe that we
have
resolved this issue through a new gel formulation of Topical PTH (1-34) and
have
filed new patent applications in the U.S. for this new proprietary
formulation.
In
September 2007, the U.S. FDA accepted our corporate Investigational New Drug
(IND) application for this new gel formulation of Topical PTH (1-34), and in
October 2007, we initiated and began dosing subjects in a phase 2a clinical
study of Topical PTH (1-34) for the treatment of psoriasis. This U.S.
multi-center, randomized, double-blind, vehicle-controlled, parallel group
study
is desiged to evaluate safety and preliminary efficacy of Topical PTH (1-34)
for
the treatment of psoriasis. Approximately 54 subjects will be enrolled and
randomized to receive one of two dose levels of Topical PTH (1-34), or vehicle,
for an 8 week treatment period. In this study the vehicle is the topical
formulation without the active ingredient, PTH (1-34).
To
date,
we have incurred $5,122,000 of project costs related to our development of
Topical PTH (1-34). These project costs have been incurred since April 1, 2005,
the date of the Tarpan Therapeutics acquisition. During 2007, $2,426,000 of
these costs were incurred.
As
with
the development of our other product candidates, we do not currently have
sufficient capital to fund our planned development activities of Topical PTH
(1-34) beyond the ongoing phase 2a trial. We will, therefore, need to raise
additional capital in order to complete our planned R&D activities for
Topical PTH (1-34) . To the extent additional capital is not available when
we
need it, we may be forced to sublicense our rights to Topical PTH (1-34) or
abandon our development efforts altogether, either of which would have a
material adverse effect on the prospects of our business.
39
Since
PTH
(1-34) is already available in the injectable form, we should be able to utilize
much of the data that is publicly available in planning our future studies.
However, since PTH (1-34) will be used topically, bridging studies will need
to
be performed and we are not able to realistically predict the size and the
design of those studies at this time.
Altoderm
We
are
developing Altoderm for the pruritis (itch) associated with dermatologic
conditions including atopic dermatitis. In a Phase 3, randomized, double-blind,
placebo-controlled, parallel-group, clinical study (conducted in Europe by
T&R.) the compound was administered for 12 weeks to 114 subjects with
moderately severe atopic dermatitis. The placebo (vehicle) used in this study
was the Altoderm product without the active ingredient. In the study results,
published in the British Journal of Dermatology in February 2005, Altoderm
demonstrated a statistically significant reduction (36%) in atopic dermatitis
symptoms. During the study, subjects were permitted to continue with their
existing treatment, in most cases this consisted of emollients and topical
steroids. A positive secondary outcome of the study was a 35% reduction in
the
use of topical steroids for the Altoderm treated subjects. Further analysis
of
the clinical data, performed by Manhattan Pharmaceuticals showed that Altoderm
treated subjects also experienced a 57% reduction in pruritus.
Altoderm
is currently being tested in a second, ongoing Phase 3, randomized,
double-blind, vehicle-controlled clinical study (also conducted in Europe by
T&R). Analysis of the preliminary data from the initial 12 week, blinded
portion of this clinical trial has been completed. The vehicle used in this
study was the Altoderm product without the active ingredient, cromolyn sodium.
The preliminary data indicate Altoderm was safe and well tolerated, and showed
a
trend toward improvement in pruritus, but the efficacy results were
inconclusive. Altoderm treated subjects and vehicle only treated subjects
experienced a similar improvement (each greater than 30%), and therefore, the
study did not achieve statistical significance. The Company believes these
outcomes were due to suboptimal study design where subjects were unrestricted
in
their use of concomitant therapies such as topical steroids and
immunomodulators. The placebo (vehicle) used in this study was the Altoderm
product without the active ingredient, cromolyn sodium. Analysis of the
preliminary open label data beginning at week 13 of the study, show vehicle
treated subjects demonstrating further improvement when switched to Altoderm.
Given the promising clinical data obtained from the first European Phase 3
study, and the symptom improvements reported in the ongoing European Phase
3
study, both Manhattan Pharmaceuticals and Thornton & Ross Limited believe
there is significant potential for Altoderm and will continue development of
this product candidate.
On
March
6, 2008, Manhattan Pharmaceuticals announced it had successfully completed
a
pre-IND meeting with the FDA. Based on a review of the submitted package for
Altoderm, including data from the two previously reported Phase 3 clinical
studies, the FDA determined that following completion of certain nonclinical
studies, and the acceptance of an IND, Phase 2 clinical studies may be initiated
in the U.S. The FDA also concurred that the proposed indication of pruritus
associated with dermatologic conditions including atopic dermatitis can be
pursued.
To
date
we have incurred $1,012,000 for the development of Altoderm. All of such costs
were incurred in 2007.
40
Altolyn
We
are
developing Altolyn for the treatment of mastocystosis. On March 6, 2008,
Manhattan Pharmaceuticals announced it had successfully completed a pre-IND
meeting with the FDA. Based on a review of the submitted package for Altolyn,
the FDA concurred that the proposed indication of mastocytosis can be pursued
and that the 505(b)(2) NDA would be an acceptable approach provided a clinical
bridge is established between Altolyn and Gastrocrom®,
the
oral liquid formulation of cromolyn sodium currently approved in the U.S. to
treat mastocytosis. The FDA also affirmed that a single, Phase 3 study
demonstrating the efficacy of Altolyn over placebo, may be sufficient to support
a product approval in the U.S. In addition, the FDA also concurs that no
additional nonclinical studies will be required to support an IND application.
The Company is working with T&R and the current U.K. manufacturer of Altolyn
to develop a GMP compliant manufacturing process.
Early
clinical experience with Altolyn in the U.K. suggests promising activity in
patients with various allergic disorders, including food allergy and
inflammatory bowel conditions. The Company may pursue these as additional
indications.
To
date
we have incurred $790,000 for the development of Altolyn. All of such costs
were
incurred in 2007.
Oleoyl-estrone
On
July
9, 2007, the Company announced the results of its two Phase 2a clinical trials
of oral OE. The results of both randomized, double-blind, placebo controlled
studies, one in common obesity and the other in morbid obesity, demonstrated
no
statistically or clinically meaningful placebo adjusted weight loss for any
of
the treatment arms evaluated. Based on these results, the Company discontinued
its Oleoyl-estrone programs in both common obesity and morbid
obesity.
To
date,
we have incurred $15,510,000 for the development of OE, $3,209,000 of which
was
incurred during 2007.
Propofol
Lingual Spray
On
July
9, 2007, the Company announced that it discontinued development of Propofol
Lingual Spray for pre-procedural sedation.
To
date,
we have incurred $2,984,000 for the development of Propofol Lingual Spray,
$27,000 of which was incurred during 2007.
Summary
of Contractual Commitments
Employment
Agreements
We
have
employment agreements with two employees for the payment of aggregate annual
base salaries of $530,000 as well as performance based bonuses. All of these
agreements have terms of three years and have a remaining obligation of $394,000
as of December 31, 2007.
41
Leases
Rent
expense for the years ended December 31, 2007 and 2006 was $141,012 and
$141,012, respectively. Future minimum rental payments subsequent to December
31, 2007 under an operating lease for the Company’s office facility are as
follows:
Years
Ending December 31,
|
Commitment
|
|
2008
|
$100,000
|
|
2009
and subsequent
|
$0
|
Off-Balance
Sheet Arrangements
We
have
not entered into any off-balance sheet arrangements.
Critical
Accounting Policies
In
December 2001, the SEC requested that all registrants discuss their most
“critical accounting policies” in management’s discussion and analysis of
financial condition and results of operations. The SEC indicated that a
“critical accounting policy” is one which is both important to the portrayal of
the company’s financial condition and results and requires management’s most
difficult, subjective or complex judgments, often as a result of the need to
make estimates about the effect of matters that are inherently
uncertain.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect certain reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and the reported amounts of expenses during the
reporting period. Actual results could differ from those estimates.
Research
and development expenses
All
research and development costs are expensed as incurred and include costs of
consultants who conduct research and development on behalf of the Company and
its subsidiaries. Costs related to the acquisition of technology rights and
patents for which development work is still in process are expensed as incurred
and considered a component of research and development costs.
The
Company often contracts with third parties to facilitate, coordinate and perform
agreed upon research and development of a new drug. To ensure that research
and
development costs are expensed as incurred, the Company records monthly accruals
for clinical trials and preclinical testing costs based on the work performed
under the contracts.
These
contracts typically call for the payment of fees for services at the initiation
of the contract and/or upon the achievement of certain milestones. This method
of payment often does not match the related expense recognition resulting in
either a prepayment, when the amounts paid are greater than the related research
and development costs expensed, or an accrued liability, when the amounts paid
are less than the related research and development costs expensed.
42
Share-Based
Compensation
We
have
stockholder-approved stock incentive plans for employees, directors, officers
and consultants. Prior to January 1, 2006, we accounted for the employee,
director and officer plans using the intrinsic value method under the
recognition and measurement provisions of Accounting Principles Board (“APB”)
Opinion No.25, “Accounting for Stock Issued to Employees” and related
interpretations, as permitted by Statement of Financial Accounting Standards
(“SFAS” or “Statement”) No. 123, “Accounting for Stock-Based Compensation.”
Effective
January 1, 2006, we adopted SFAS No. 123(R), “Share-Based Payment,” (“Statement
123(R)”) for employee options using the modified prospective transition method.
Statement 123(R) revised Statement 123 to eliminate the option to use the
intrinsic value method and required us to expense the fair value of all employee
options over the vesting period. Under the modified prospective transition
method, we recognized compensation cost for the years ended December 31,2007
and
2006 which includes a) period compensation cost related to share-based payments
granted prior to, but not yet vested, as of January 1, 2006, based on the grant
date fair value estimated in accordance with the original provisions of
Statement 123; and b) period compensation cost related to share-based payments
granted on or after January 1, 2006, based on the grant date fair value
estimated in accordance with Statement 123(R). In accordance with the modified
prospective method, we have not restated prior period results.
New
Accounting Pronouncements
In
September 2006, the FASB issued SFAS No. 157, “Fair
Value Measurements” (“SFAS 157”), which defines fair value, establishes a
framework for measuring fair value in accordance with generally accepted
accounting principles (“GAAP”) in the United States of America, and expands
disclosures about fair value measurements. SFAS 157 does not require any
new
fair value measurements under GAAP and is effective for fiscal years beginning
after November 15, 2007. The Company will adopt SFAS 157 as of January 1,
2008.
The effects of adoption will be determined by the types of instruments carried
at fair value in our financial statements at the time of adoption, as well
as
the method utilized to determine their fair values prior to adoption. Based
on
the Company’s current use of fair value measurements, SFAS 157 is not expected
to have a material effect on its results of operations or financial
position.
In
February 2007, the FASB issued SFAS No. 159, “The
Fair
Value Option for Financial Assets and Financial Liabilities,” (“SFAS 159”),
which provides companies with an option to report selected financial assets
and
liabilities at fair value. SFAS 159 establishes presentation and disclosure
requirements designed to facilitate comparisons between companies that choose
different measurement attributes for similar types of assets and liabilities
and
highlights the effect of a company’s choice to use fair value on its earnings.
It also requires a company to display the fair value of those assets and
liabilities for which it has chosen to use fair value on the face of the
balance
sheet. SFAS 159 will be effective beginning January 1, 2008 and is not expected
to have a material impact on the Company’s consolidated financial
statements.
In
June
2007, the FASB issued EITF No. 07-3, “Accounting
for Nonrefundable Advance Payments for Goods or Services Received for use
in
Future Research and Development Activities” (“EITF No. 07-3”). EITF No. 07-3
states that nonrefundable advance payments for goods or services that will
be
used or rendered for future research and development activities should be
deferred and capitalized. Such amounts should be recognized as an expense
as the
related goods are delivered or the related services are performed. Entities
should continue to evaluate whether they expect the goods to be delivered
or
services to be rendered. If an entity does not expect the goods to be delivered
or services to be rendered, the capitalized advance payment should be charged
to
expense. The provisions of EITF No. 07-3 will be effective for the Company
on a
prospective basis beginning January 1, 2008, evaluated on a contract by contract
basis and is not expected to have a material impact on the Company’s
consolidated financial statements.
43
In
December 2007, the FASB issued SFAS No. 141(R), a revised version of SFAS
No.
141, “Business
Combinations.” The revision is intended to simplify existing guidance and
converge rulemaking under U.S. generally accepted accounting principles with
international accounting standards. This statement applies prospectively
to
business combinations where the acquisition date is on or after the beginning
of
the first annual reporting period beginning on or after December 15, 2008.
An
entity may not apply it before that date. The Company is currently evaluating
the impact of the provisions of the revision on its consolidated results
of
operations and financial condition.
In
December 2007, the FASB issued SFAS No. 160,“Noncontrolling
Interests in Consolidated Financial Statements” (SFAS 160), which will require
noncontrolling interests (previously referred to as minority interests) to
be
treated as a separate component of equity, not as a liability or other item
outside of permanent equity. This statement applies to the accounting for
noncontrolling interests and transactions with noncontrolling interest holders
in consolidated financial statements. SFAS 160 will be applied prospectively
to
all noncontrolling interests, including any that arose before the effective
date
except that comparative period information must be recast to classify
noncontrolling interests in equity, attribute net income and other comprehensive
income to noncontrolling interests, and provide other disclosures required
by
Statement 160. SFAS 160 is effective for periods beginning on or after December
15, 2008. We are currently evaluating the impact that SFAS 160 will have
on our
consolidated financial statements.
The
FASB
and the Securities and Exchange Commission had issued certain other accounting
pronouncements as of December 31, 2007 that will become effective in subsequent
periods; however, the Company does not believe that any of those pronouncements
would have significantly affected its financial accounting measures or
disclosures had they been in effect during the years ended December 31, 2007
and
2006 and for the period from August 6, 2001 (inception) to December 31, 2007
or
that will have a significant effect at the time they become
effective.
44
ITEM
7. CONSOLIDATED FINANCIAL STATEMENTS
For
a
list of the consolidated financial statements filed as part of this report,
see
the Index to Consolidated Financial Statements beginning at Page F-1 of this
Annual Report.
ITEM
8.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM
8A(T). CONTROLS
AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
As
of
December 31, 2007, we carried out an evaluation, under the supervision and
with
the participation of our Chief Executive Officer and Chief Financial Officer,
of
the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rules13a-15(e) and 15d-15(e) of the Securities
Exchange Act of 1934, as amended). Based upon that evaluation, our Chief
Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures were effective as of that date in alerting them on
a
timely basis to material information required to be disclosed our reports to
the
Securities and Exchange Commission. There were no changes in our internal
controls over financial reporting during the quarter ended December 31, 2007
that have materially affected, or are likely to materially affect, our internal
controls over financial reporting.
Our
management, including our Chief Executive Officer and its Chief Financial
Officer, does not expect that disclosure controls or internal controls over
financial reporting will prevent all errors or all instances of fraud, even
as
the same are improved to address any deficiencies. The design of any system
of
controls is based in part upon certain assumptions about the likelihood of
future events, and there can be no assurance that any design will succeed in
achieving its stated goals under all potential future conditions. A control
system, no matter how well designed and operated, can provide only reasonable,
not absolute, assurance that the control system’s objectives will be met. Over
time, controls may become inadequate because of changes in conditions or
deterioration in the degree of compliance with policies or procedures. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances
of fraud, if any, within the Company have been detected.
Because
of the inherent limitation of a cost-effective control system, misstatements
due
to error or fraud may occur and not be detected. These inherent limitations
include the realities that judgments in decision-making can be faulty, and
that
breakdowns can occur because of a simple error or mistake. Controls can also
be
circumvented by the individual acts of some persons, by collusion of two or
more
people, or by management override of the controls.
Management’s
Report on Internal Control
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting and for the assessment of the effectiveness
of
internal control over financial reporting. As defined by the SEC, internal
control over financial reporting is a process designed by, or under the
supervision of our principal executive and principal financial officers and
effected by our Board of Directors, management and other personnel, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of the financial statements in accordance with U.S. generally
accepted accounting principles.
45
Our
internal control over financial reporting includes those policies and procedures
that (1) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect our transactions and dispositions of our assets;
(2) provide reasonable assurance that transactions are recorded as necessary
to
permit preparation of the financial statements in accordance with U.S. generally
accepted accounting principles, and that our receipts and expenditures are
being
made only in accordance with authorizations of our management and directors;
and
(3) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of our assets that could have
a
material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. Also projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In
connection with the preparation of our annual financial statements, management
has undertaken an assessment of the effectiveness of our internal control over
financial reporting as of December 31, 2007, based on criteria established
in
Internal Control - Integrated framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission, or COSO Framework. Management’s
assessment included an evaluation of the design of our internal control over
financial reporting and testing of the operational effectiveness of those
controls.
Based
on
this evaluation, management has concluded that our internal control over
financial reporting is effective as of December 31, 2007.
This
annual report does not include an attestation report of the Company’s
independent registered public accounting firm regarding internal control over
financial reporting. Management’s report was not subject to attestation by the
Company’s independent registered public accounting firm pursuant to temporary
rules of the SEC that permit the Company to provide only management’s report on
internal control in this report.
ITEM
8B. OTHER
INFORMATION
On
March
28, 2008 the employment agreement between the Company and Douglas Abel, the
Company’s president and chief executive officer, was extended by mutual
agreement for a period of one year, through April 1, 2009.
ITEM
9. DIRECTORS,
EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
Information
in response to this Item is incorporated herein by reference to our 2008 Proxy
Statement to be filed pursuant to Regulation14A within 120days after the end
of
the fiscal year covered by this Form 10-K.
46
PART
III
ITEM
10. EXECUTIVE COMPENSATION
Information
in response to this Item is incorporated herein by reference to our 2008 Proxy
Statement to be filed pursuant to Regulation14A within 120 days after the end
of
the fiscal year covered by this Form 10-K.
ITEM
11. SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDERS
MATTERS
Information
in response to this Item is incorporated herein by reference to our 2008 Proxy
Statement to be filed pursuant to Regulation 14A within 120 days after the
end
of the fiscal year covered by this Form 10-K.
ITEM
12. CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR
INDEPENDENCE
Information
in response to this Item is incorporated herein by reference to our 2008 Proxy
Statement to be filed pursuant to Regulation 14A within 120 days after the
end
of the fiscal year covered by this Form 10-K.
47
ITEM
13. EXHIBITS LIST–
REVIEW WITH ANTHONY
The
following documents are included or referenced in this report.
Exhibit
No.
|
Description
|
|
2.1
|
Agreement
and Plan of Merger among the Company, Manhattan Pharmaceuticals
Acquisition Corp. and Manhattan Research Development, Inc. (formerly
Manhattan Pharmaceuticals, Inc.) dated December 17, 2002 (incorporated
by
reference to Exhibit 2.1 from Form 8-K filed March 5,
2003).
|
|
2.2
|
Agreement
and Plan of Merger among the Registrant, Tarpan Therapeutics, Inc.
and
Tarpan Acquisition Corp., dated April 1, 2005 (incorporated by reference
to Exhibit 2.1 of the Registrant’s Form 8-K/A filed June 15,
2005).
|
|
3.1
|
Certificate
of incorporation, as amended through September 25, 2003 (incorporated
by
reference to Exhibit 3.1 to the Registrant’s Form 10-QSB for the quarter
ended September 30, 2003).
|
|
3.2
|
Bylaws,
as amended to date (incorporated by reference from Registrant’s
registration statement on Form SB-2, as amended (File
No.33-98478)).
|
|
4.1
|
Specimen
common stock certificate (incorporated by reference from Registrant’s
registration statement on Form SB-2, as amended (File
No.33-98478)).
|
|
4.2
|
Form
of warrant issued by Manhattan Research Development, Inc., which
automatically converted into warrants to purchase shares of the
Registrant’s common stock upon the merger transaction with such company
(incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-QSB
for the quarter ended March 31, 2003).
|
|
4.3
|
Form
of warrant issued to placement agents in connection with the Registrant’s
November 2003 private placement of Series A Convertible Preferred
Stock
and the Registrant’s January 2004 private placement (incorporated by
reference to Exhibit 4.18 to the Registrant’s Registration Statement on
Form SB-2 filed January 13, 2004 (File No.
333-111897)).
|
|
4.4
|
Form
of warrant issued to investors in the Registrant’s August 2005 private
placement (incorporated by reference to Exhibit 4.1 of the Registrant’s
Form 8-K filed September 1, 2005).
|
|
4.5
|
Form
of warrant issued to placement agents in the Registrant’s August 2005
private placement (incorporated by reference to Exhibit 4.2 of the
Registrant’s Form 8-K filed September 1, 2005).
|
|
10.1
|
1995
Stock Option Plan, as amended (incorporated by reference to Exhibit
10.18
to the Registrant’s Form 10-QSB for the quarter ended September 30,
1996).
|
|
10.2
|
Form
of Notice of Stock Option Grant issued to employees of the Registrant
from
April 12, 2000 to February 21, 2003 (incorporated by reference to
Exhibit
99.2 of the Registrant’s Registration Statement non Form S-8 filed March
24, 1998 (File 333-48531)).
|
48
10.3
|
Schedule
of Notices of Stock Option Grants, the form of which is attached
hereto as
Exhibit 4.2.
|
|
10.4
|
Form
of Stock Option Agreement issued to employees of the Registrant from
April
12, 2000 to February 21, 2003 (incorporated by reference to Exhibit
99.3
to the Registrant’s Registration Statement on Form S-8 filed March 24,
1998 (File 333-48531)).
|
|
10.5
|
License
Agreement dated on or about February 28, 2002 between Manhattan Research
Development, Inc. (f/k/a Manhattan Pharmaceuticals, Inc.) and
Oleoyl-Estrone Developments SL (incorporated by reference to Exhibit
10.6
to the Registrant’s Amendment No. 2 to Form 10-QSB/A for the quarter ended
March 31, 2003 filed on March 12, 2004).
|
|
10.6
|
License
Agreement dated April 4, 2003 between the Registrant and NovaDel
Pharma,
Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s
Amendment No. 1 to Form 10-QSB/A for the quarter ended June 30, 2003
filed
on March 12, 2004).++
|
|
10.7
|
2003
Stock Option Plan (incorporated by reference to Exhibit 4.1 to
Registrant’s Registration Statement on Form S-8 filed February 17,
2004).
|
|
10.8
|
Employment
Agreement dated April 1, 2005, between the Registrant and Douglas
Abel
(incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K/A
filed June 15, 2005).
|
|
10.9
|
Sublicense
Agreement dated April 14, 2004 between Tarpan Therapeutics, Inc.,
the
Registrant’s wholly-owned subsidiary, and IGI, Inc. (incorporated by
reference to Exhibit 10.109 to IGI Inc.’s Form 10-Q for the quarter ended
March 31, 2004 (File No. 001-08568).
|
|
10.10
|
Form
of subscription agreement between the Registrant and the investors
in the
Registrant’s August 2005 private placement (incorporated by reference as
Exhibit 10.1 to the Registrant’s Form 8-K filed September 1,
2005).
|
|
10.11
|
Separation
Agreement between the Registrant and Alan G. Harris December 21,
2007
|
|
10.12
|
Employment
Agreement dated July 7, 2006 between the Registrant and Michael G.
McGuinness (incorporated by reference to Exhibit 10.1 of the Registrant’s
Form 8-K filed July 12, 2006).
|
|
10.13
|
Summary
terms of compensation plan for Registrant’s non-employee directors
(incorporated by reference to Exhibit 10.1 of Registrant’s Form 8-K filed
February 5, 2007).
|
|
10.14
|
Form
of Stock Option Agreement issued under the Registrant’s 2003 Stock Option
Plan.
|
|
10.15
|
Exclusive
License Agreement for “Altoderm” between Thornton & Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dates April 3, 2007. Incorporated
by
reference to Exhibit 10.3 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14,
2007.
|
49
10.16
|
Exclusive
License Agreement for “Altolyn” between Thornton &Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dated April 3, 2007. Incorporated
by
reference to Exhibit 10.4 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14, 2007.
|
|
10.17
|
Exclusive
License Agreement for “Hedrin” between Thornton &Ross Ltd. , Kerris,
S.A. and Manhattan Pharmaceuticals, Inc. dated June 26, 2007. Incorporated
by reference to Exhibit 10.5 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14, 2007.
|
|
10.18
|
Supply
Agreement for “Hedrin” between Thornton & Ross Ltd. and Manhattan
Pharmaceuticals, Inc. dated June 26, 2007. Incorporated by reference
to
Exhibit 10.6 of the registrant’s form 10-Q for the quarter ended June 30,
2007 filed on August 14, 2007.
|
|
10.19
|
Joint
Venture Agreement between Nordic Biotech fund II K/S and Manhattan
Pharmaceuticals, Inc. to develop and commercialize “Hedrin” dated January
31, 2008.
|
|
10.20
|
Amendment
No. 1, dated February 25, 2008, to the Joint Venture Agreement between
Nordic Biotech fund II K/S and Manhattan Phaarmaceuticals, Inc. to
develop
and commercialize “Hedrin” dated January 31, 2008.
|
|
10.21
|
Assignment
and Contribution Agreement between Hedrin Pharmaceuticals K/S and
Manhattan Pharmaceuticals, Inc. dated February 25,
2008.
|
|
10.22
|
Registration
Rights Agreement between Nordic Biotech Venture Fund II K/S and Manhattan
Pharmaceuticals, Inc. dated February 25, 2008.
|
|
10.23
|
Amendment
to Employment Agreement by and between Manhattan Pharmaceuticals,
Inc. and
Douglas Abel
|
|
23.1
|
Consent
of J.H. Cohn LLP.
|
|
31.1
|
Certification
of Principal Executive Officer.
|
|
31.2
|
Certification
of Principal Financial Officer.
|
|
32.1
|
Certifications
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
++
|
Confidential
treatment has been granted as to certain portions of this exhibit
pursuant
to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
|
50
ITEM
14. PRINCIPAL
ACCOUNTANT FEES AND SERVICES.
Fees
Billed to the Company by Its Independent Auditors – MIKE TO
UPDATE
The
following is a summary of the fees billed to us by J.H. Cohn LLP, our
independent registered public accounting firm for professional services rendered
for fiscal years ended December 31, 2007 and 2006:
J.H.
Cohn LLP
|
|||||||
Fee
Category
|
Fiscal
2007 Fees
|
Fiscal
2006 Fees
|
|||||
Audit
Fees
|
$
|
103,940
|
$
|
100,111
|
|||
Audit-Related
Fees (1)
|
11,520
|
22,943
|
|||||
Tax
Fees (2)
|
18,708
|
21,165
|
|||||
All
Other Fees (3)
|
-
|
-
|
|||||
Total
Fees
|
$
|
134,168
|
$
|
144,219
|
(1) Audit-Related
Fees consist principally of assurance and related services that are reasonably
related to the performance of the audit or review of the Company’s financial
statements but not reported under the caption “Audit Fees.” These fees include
review of registration statements.
(2) Tax
Fees
consist of fees for tax compliance, tax advice and tax planning.
(3) All
Other
Fees consist of aggregate fees billed for products and services provided by
the
independent registered public accounting firm, other than those disclosed
above.
Policy
on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services
of
Independent Registered Public Accounting Firm
At
present, our audit committee approves each engagement for audit or non-audit
services before we engage our independent registered public accounting firm
to
provide those services. Our audit committee has not established any pre-approval
policies or procedures that would allow our management to engage our independent
registered public accounting firm to provide any specified services with only
an
obligation to notify the audit committee of the engagement for those services.
None of the services provided by our independent registered public accounting
firm for fiscal 2007 was obtained in reliance on the waiver of the pre-approval
requirement afforded in SEC regulations.
51
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act,
of
1934, the registrant has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized, on March 31, 2008.
Manhattan
Pharmaceuticals, Inc.
|
|
By:
|
/s/
Douglas Abel
|
Douglas
Abel
|
|
Chief
Executive Officer and President
|
In
accordance with the Securities Exchange Act,
this
report has been signed below by the following persons on behalf of Manhattan
Pharmaceuticals, Inc. and in the capacities and on the dates
indicated.
Signature
|
Title
|
Date
|
||
/s/
Douglas Abel
|
Chief
Executive Officer, President and
|
March
31, 2008
|
||
Douglas
Abel
|
Director (principal executive officer) | |||
/s/
Michael G. McGuinness
|
Secretary
and Chief Financial Officer
|
March
31, 2008
|
||
Michael
G. McGuinness
|
(principal accounting and financial officer) | |||
/s/
Neil Herskowitz
|
Director
|
March
31, 2008
|
||
Neil
Herskowitz
|
||||
/s/
Malcolm Hoenlein
|
Director
|
March
31, 2008
|
||
Malcolm
Hoenlein
|
||||
/s/
Timothy McInerney
|
Director
|
March
31, 2008
|
||
Timothy
McInerney
|
||||
/s/
Richard Steinhart
|
Director
|
March
31, 2008
|
||
Richard
Steinhart
|
||||
/s/
Michael Weiser
|
Director
|
March
31, 2008
|
||
Michael
Weiser
|
52
Index
to Consolidated Financial Statements
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
F-3
|
Consolidated
Statements of Operations for the Years Ended December 31, 2007 and
2006
and the cumulative period from August 6, 2001 (inception) to December
31,
2007
|
F-4
|
Consolidated
Statement of Stockholders’ Equity (Deficiency) for the Years Ended
December
31, 2007 and 2006 and the cumulative period from August 6, 2001
(inception) to December 31, 2007
|
F-5
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2007 and
2006
and the cumulative period from August 6, 2001 (inception) to December
31,
2007
|
F-7
|
Notes
to Consolidated Financial Statements
|
F-8
|
F-1
REPORT
OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The
Board
of Directors and Stockholders
Manhattan
Pharmaceuticals, Inc.
We
have
audited the accompanying consolidated balance sheets of Manhattan
Pharmaceuticals, Inc. and Subsidiaries (a development stage company) as of
December 31, 2007 and 2006, and the related consolidated statements of
operations, stockholders' equity (deficiency) and cash flows for the years
then
ended, and for the period from August 6, 2001 (date of inception) to December
31, 2007. These consolidated financial statements are the responsibility of
the
Company's management. Our responsibility is to express an opinion on these
consolidated financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining,
on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the consolidated financial position of Manhattan
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2007 and 2006, and
their consolidated results of operations and cash flows for the years then
ended
and for the period from August 6, 2001 (date of inception) to December 31,
2007,
in conformity with accounting principles generally accepted in the United States
of America.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 2 to the
consolidated financial statements, the Company has incurred net losses and
negative cash flows from operating activities from its inception through
December 31, 2007 and has an accumulated deficit and negative working capital
as
of December 31, 2007. These matters raise substantial doubt about the Company’s
ability to continue as a going concern. Management’s plan regarding these
matters are also described in Note 2. The accompanying consolidated financial
statements do not include any adjustments that might result from the outcome
of
this uncertainty.
As
discussed in Note 3 to the consolidated financial statements, the Company
changed the manner in which it accounts for share-based compensation in fiscal
2006.
/s/
J.H.
Cohn LLP
Roseland,
New Jersey
March
28,
2008
F-2
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Consolidated
Balance Sheets
December
31, 2007
|
December
31, 2006
|
||||||
Assets
|
|
||||||
Current
assets:
|
|
||||||
Cash
and cash equivalents
|
$
|
649,686
|
$
|
3,029,118
|
|||
Prepaid
expenses
|
215,852
|
264,586
|
|||||
|
|||||||
Total
current assets
|
865,538
|
3,293,704
|
|||||
|
|||||||
Property
and equipment, net
|
44,533
|
83,743
|
|||||
Other
assets
|
70,506
|
70,506
|
|||||
|
|||||||
Total
assets
|
$
|
980,577
|
$
|
3,447,953
|
|||
|
|||||||
Liabilities
and Stockholders’ Equity (Deficiency)
|
|
||||||
|
|||||||
Current
liabilities:
|
|
||||||
Accounts
payable
|
$
|
1,279,485
|
$
|
1,393,296
|
|||
Accrued
expenses
|
592,177
|
550,029
|
|||||
|
|||||||
Total
liabilities
|
1,871,662
|
1,943,325
|
|||||
|
|||||||
Commitments
and contingencies
|
|
||||||
|
|||||||
Stockholders’
equity (deficiency):
|
|
||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares issued
and
outstanding at December 31, 2007 and 2006
|
|||||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,624,232
and
60,120,038 shares issued and outstanding at December 31, 2007 and
December 31, 2006, respectively
|
70,624
|
60,120
|
|||||
Additional
paid-in capital
|
54,037,361
|
44,411,326
|
|||||
Deficit
accumulated during the development stage
|
(54,999,070
|
)
|
(42,966,818
|
)
|
|||
|
|||||||
Total
stockholders’ equity (deficiency)
|
(891,085
|
)
|
1,504,628
|
||||
|
|||||||
Total
liabilities and stockholders' equity (deficiency)
|
$
|
980,577
|
$
|
3,447,953
|
See
accompanying notes to consolidated financial statements.
F-3
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Consolidated
Statements of Operations
Years ended December 31,
|
Cumulative
period from
August 6, 2001
(inception) to
December 31,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
Revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Costs
and expenses:
|
||||||||||
Research
and development
|
8,535,687
|
6,172,845
|
26,489,043
|
|||||||
General
and administrative
|
3,608,270
|
3,827,482
|
13,852,363
|
|||||||
In-process
research and development charge
|
—
|
—
|
11,887,807
|
|||||||
Impairment
of intangible assets
|
—
|
—
|
1,248,230
|
|||||||
Loss
on disposition of intangible assets
|
—
|
—
|
1,213,878
|
|||||||
Total
operating expenses
|
12,143,957
|
10,000,327
|
54,691,321
|
|||||||
Operating
loss
|
(12,143,957
|
)
|
(10,000,327
|
)
|
(54,691,321
|
)
|
||||
Other
(income) expense:
|
||||||||||
Interest
and other income
|
(112,181
|
)
|
(307,871
|
)
|
(821,897
|
)
|
||||
Interest
expense
|
476
|
1,665
|
26,034
|
|||||||
Realized
(gain)/loss on sale of marketable equity securities
|
—
|
1,002
|
(76,032
|
)
|
||||||
Total
other income
|
(111,705
|
)
|
(305,204
|
)
|
(871,895
|
)
|
||||
Net
loss
|
(12,032,252
|
)
|
(9,695,123
|
)
|
(53,819,426
|
)
|
||||
Preferred
stock dividends (including imputed amounts)
|
—
|
—
|
(1,179,644
|
)
|
||||||
Net
loss applicable to common shares
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(54,999,070
|
)
|
|
Net
loss per common share:
|
||||||||||
Basic
and diluted
|
$
|
(0.18
|
)
|
$
|
(0.16
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||
Basic
and diluted
|
68,015,075
|
60,112,333
|
See
accompanying notes to consolidated financial statements.
F-4
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Consolidated
Statement of Stockholders’ Equity (Deficiency)
Series
A convertible preferred stock
|
Series
A convertible preferred stock
|
Common
stock
|
Common
stock
|
Additional
paid-in capital
|
Subscription
receivable
|
Deficit
accumulated during development stage
|
Dividends
payable in
Series A
preferred
stock
|
Accumulated
other
comprehensive
income (loss)
|
Unearned
consulting services
|
Total
stockholders’ equity (deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||||
Stock
issued at $0.0004 per share for subscription receivable
|
—
|
$
|
—
|
10,167,741
|
$
|
10,168
|
$
|
(6,168
|
)
|
$
|
(4,000
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2001
|
—
|
—
|
10,167,741
|
10,168
|
(6,168
|
)
|
(4,000
|
)
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||
Proceeds
from subscription receivable
|
—
|
—
|
—
|
—
|
—
|
4,000
|
—
|
—
|
—
|
—
|
4,000
|
|||||||||||||||||||||||
Stock
issued at $0.0004 per share for license rights
|
—
|
—
|
2,541,935
|
2,542
|
(1,542
|
)
|
—
|
—
|
—
|
—
|
—
|
1,000
|
||||||||||||||||||||||
Stock
options issued for consulting services
|
—
|
—
|
—
|
—
|
60,589
|
—
|
—
|
—
|
—
|
(60,589
|
)
|
—
|
||||||||||||||||||||||
Amortization
of unearned consulting services
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22,721
|
22,721
|
|||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
3,043,332
|
3,043
|
1,701,275
|
—
|
—
|
—
|
—
|
—
|
1,704,318
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(1,037,320
|
)
|
—
|
—
|
—
|
(1,037,320
|
)
|
||||||||||||||||||||||
Balance
at December 31, 2002
|
—
|
—
|
15,753,008
|
15,753
|
1,754,154
|
—
|
(1,094,116
|
)
|
—
|
—
|
(37,868
|
)
|
637,923
|
|||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
1,321,806
|
1,322
|
742,369
|
—
|
—
|
—
|
—
|
—
|
743,691
|
|||||||||||||||||||||||
Effect
of reverse acquisition
|
—
|
—
|
6,287,582
|
6,287
|
2,329,954
|
—
|
—
|
—
|
—
|
—
|
2,336,241
|
|||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
37,868
|
37,868
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(7,760
|
)
|
—
|
(7,760
|
)
|
|||||||||||||||||||||
Payment
for fractional shares for stock combination
|
—
|
—
|
—
|
—
|
(300
|
)
|
—
|
—
|
—
|
—
|
—
|
(300
|
)
|
|||||||||||||||||||||
Preferred
stock issued at $10 per share, net of expenses
|
1,000,000
|
1,000
|
—
|
—
|
9,045,176
|
—
|
—
|
—
|
—
|
—
|
9,046,176
|
|||||||||||||||||||||||
Imputed
preferred stock dividend
|
418,182
|
—
|
(418,182
|
)
|
—
|
—
|
||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,960,907
|
)
|
—
|
—
|
—
|
(5,960,907
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2003
|
1,000,000
|
1,000
|
23,362,396
|
23,362
|
14,289,535
|
—
|
(7,473,205
|
)
|
—
|
(7,760
|
)
|
—
|
6,832,932
|
|||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
27,600
|
27
|
30,073
|
—
|
—
|
—
|
—
|
—
|
30,100
|
|||||||||||||||||||||||
Common
stock issued at $1.10, net of expenses
|
—
|
—
|
3,368,952
|
3,369
|
3,358,349
|
—
|
—
|
—
|
—
|
—
|
3,361,718
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(585,799
|
)
|
585,799
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
24,901
|
25
|
—
|
—
|
281,073
|
—
|
—
|
(282,388
|
)
|
—
|
—
|
(1,290
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(170,528
|
(171
|
1,550,239
|
1,551
|
(1,380
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||
Warrants
issued for consulting services
|
—
|
—
|
—
|
—
|
125,558
|
—
|
—
|
—
|
—
|
(120,968
|
)
|
4,590
|
||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100,800
|
100,800
|
|||||||||||||||||||||||
Unrealized
gain on short-term investments and reversal of unrealized loss on
short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20,997
|
—
|
20,997
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,896,031
|
)
|
—
|
—
|
—
|
(5,896,031
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2004
|
854,373
|
854
|
28,309,187
|
28,309
|
18,083,208
|
—
|
(13,955,035
|
)
|
303,411
|
13,237
|
(20,168
|
)
|
4,453,816
|
F-5
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Consolidated
Statement of Stockholders’ Equity (Deficiency)
Series
A convertible preferred stock
|
Series
A convertible preferred stock
|
Common
stock
|
Common
stock
|
Additional
paid-in capital
|
Subscription
receivable
|
Deficit
accumulated during development stage
|
Dividends
payable in Series A preferred stock
|
Accumulated
other comprehensive income (loss)
|
Unearned
consulting services
|
Total
stockholders’ equity (deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||||
Common
stock issued at $1.11 and $1.15, net of expenses
|
—
|
—
|
11,917,680
|
11,918
|
12,238,291
|
—
|
—
|
—
|
—
|
—
|
12,250,209
|
|||||||||||||||||||||||
Common
stock issued to vendor at $1.11 per share in satisfaction of accounts
payable
|
—
|
—
|
675,675
|
676
|
749,324
|
—
|
—
|
—
|
—
|
—
|
750,000
|
|||||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
32,400
|
33
|
32,367
|
—
|
—
|
—
|
—
|
—
|
32,400
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
279,845
|
279
|
68,212
|
—
|
—
|
—
|
—
|
—
|
68,491
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(175,663
|
)
|
175,663
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
41,781
|
42
|
—
|
—
|
477,736
|
—
|
—
|
(479,074
|
)
|
—
|
—
|
(1,296
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(896,154
|
)
|
(896
|
)
|
8,146,858
|
8,147
|
(7,251
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
66,971
|
—
|
—
|
—
|
—
|
20,168
|
87,139
|
|||||||||||||||||||||||
Reversal
of unrealized gain on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,250
|
)
|
—
|
(12,250
|
)
|
|||||||||||||||||||||
Stock
issued in connection with acquisition of Tarpan Therapeutics,
Inc.
|
—
|
—
|
10,731,052
|
10,731
|
11,042,253
|
—
|
—
|
—
|
—
|
—
|
11,052,984
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(19,140,997
|
)
|
—
|
—
|
—
|
(19,140,997
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2005
|
—
|
—
|
60,092,697
|
60,093
|
42,751,111
|
—
|
(33,271,695
|
)
|
—
|
987
|
—
|
9,540,496
|
||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
27,341
|
27
|
(27
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,675,499
|
—
|
—
|
—
|
—
|
—
|
1,675,499
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(987
|
)
|
—
|
(987
|
)
|
|||||||||||||||||||||
Costs
associated with private placement
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
—
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(9,695,123
|
)
|
—
|
—
|
—
|
(9,695,123
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2006
|
—
|
—
|
60,120,038
|
60,120
|
44,411,326
|
—
|
(42,966,818
|
)
|
—
|
—
|
—
|
1,504,628
|
||||||||||||||||||||||
Common
stock issued at $0.84 and $0.90 per shares, net of
expenses
|
—
|
—
|
10,185,502
|
10,186
|
7,841,999
|
—
|
—
|
—
|
—
|
—
|
7,852,185
|
|||||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction of accounts
payable
|
—
|
—
|
27,776
|
28
|
19,972
|
—
|
—
|
—
|
—
|
—
|
20,000
|
|||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.90
per
share
|
—
|
—
|
125,000
|
125
|
112,375
|
—
|
—
|
—
|
—
|
—
|
112,500
|
|||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.80
per
share
|
—
|
—
|
150,000
|
150
|
119,850
|
—
|
—
|
—
|
—
|
—
|
120,000
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,440,956
|
—
|
—
|
—
|
—
|
—
|
1,440,956
|
|||||||||||||||||||||||
Warrants
issued for consulting
|
83,670
|
83,670
|
||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,032,252
|
)
|
—
|
—
|
—
|
(12,032,252
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2007
|
—
|
—
|
$ |
70,624,232
|
70,624
|
$ |
54,037,361
|
$
|
—
|
$
|
(54,999,070
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(891,085
|
)
|
See
accompanying notes to consolidated financial statements.
F-6
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Consolidated
Statements of Cash Flows
Years ended December 31,
|
Cumulative
period from
August 6, 2001
(inception) to
December 31,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(53,819,426
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Share-based
compensation
|
1,440,956
|
1,675,499
|
3,364,983
|
|||||||
Shares
issued in connection with in-licensing agreement
|
232,500
|
—
|
232,500
|
|||||||
Warrants
issued to consultant
|
83,670
|
—
|
83,670
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
(Gain)/loss
on sale of marketable equity securities
|
—
|
1,002
|
(76,032
|
)
|
||||||
Depreciation
|
48,345
|
60,186
|
195,825
|
|||||||
Non
cash portion of in-process research and development charge
|
—
|
—
|
11,721,623
|
|||||||
Loss
on impairment and disposition of intangible assets
|
—
|
—
|
2,462,108
|
|||||||
Other
|
—
|
—
|
5,590
|
|||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||
Decrease
(increase) in prepaid expenses and other current assets
|
48,734
|
(69,810
|
)
|
(157,607
|
)
|
|||||
Increase
in other assets
|
—
|
—
|
(70,506
|
)
|
||||||
Increase
(decrease) in accounts payable
|
(93,812
|
)
|
(224,193
|
)
|
1,699,698
|
|||||
Increase
in accrued expenses
|
42,148
|
501,701
|
51,856
|
|||||||
Net
cash used in operating activities
|
(10,229,711
|
)
|
(7,750,738
|
)
|
(34,160,556
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(9,134
|
)
|
(37,052
|
)
|
(230,635
|
)
|
||||
Cash
paid in connection with acquisitions
|
—
|
—
|
(26,031
|
)
|
||||||
Net
cash provided from the purchase and sale of short-term
investments
|
—
|
1,005,829
|
435,938
|
|||||||
Proceeds
from sale of license
|
—
|
—
|
200,001
|
|||||||
Net
cash (used in) provided by investing activities
|
(9,134
|
)
|
968,777
|
379,273
|
||||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
—
|
—
|
(884,902
|
)
|
||||||
Proceeds
(costs) related to sale of common stock, net
|
7,852,185
|
(15,257
|
)
|
25,896,262
|
||||||
Proceeds
from sale of preferred stock, net
|
—
|
—
|
9,046,176
|
|||||||
Proceeds
from exercise of warrants and stock options
|
7,228
|
—
|
138,219
|
|||||||
Other,
net
|
—
|
—
|
235,214
|
|||||||
Net
cash provided by (used in) financing activities
|
7,859,413
|
(15,257
|
)
|
34,430,969
|
||||||
Net
(decrease) increase in cash and cash equivalents
|
(2,379,432
|
)
|
6,797,218
|
649,686
|
||||||
Cash
and cash equivalents at beginning of period
|
3,029,118
|
9,826,336
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
649,686
|
$
|
3,029,118
|
$
|
649,686
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
475
|
$
|
1,665
|
$
|
26,033
|
||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||
Common
stock issued in satisfaction of accounts payable
|
$
|
20,000
|
$
|
—
|
$
|
770,000
|
||||
Imputed
preferred stock dividend
|
—
|
—
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
—
|
—
|
761,462
|
|||||||
Conversion
of preferred stock to common stock
|
—
|
—
|
1,067
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
—
|
—
|
759,134
|
|||||||
Issuance
of common stock for acquisitions
|
—
|
—
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreement
|
232,500
|
232,500
|
||||||||
Marketable
equity securities received in connection with sale of
license
|
—
|
—
|
359,907
|
|||||||
Warrants
issued to consultant
|
83,670
|
—
|
83,670
|
|||||||
Net
liabilities assumed over assets acquired in business
combination
|
—
|
—
|
(675,416
|
)
|
||||||
Cashless
exercise of warrants
|
6
|
27
|
33
|
See
accompanying notes to consolidated financial statements.
F-7
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
(1)
Merger and Nature of Operations
2003
Reverse Merger
On
February 21, 2003, the Company (formerly known as “Atlantic Technology Ventures,
Inc.”) completed a reverse acquisition of privately held Manhattan Research
Development, Inc. (“Manhattan Research”) (formerly Manhattan Pharmaceuticals,
Inc.), a Delaware corporation. At the effective time of the merger, the
outstanding shares of common stock of Manhattan Research automatically converted
into shares of the Company’s common stock representing 80 percent of the
Company’s outstanding voting stock after giving effect to the merger. Since the
stockholders of Manhattan Research received the majority of the voting shares
of
the Company, the merger was accounted for as a reverse acquisition whereby
Manhattan Research was the accounting acquirer (legal acquiree) and the Company
was the accounting acquiree (legal acquirer) under the purchase method of
accounting. In connection with the merger, the Company changed its name from
“Atlantic Technology Ventures, Inc.” to “Manhattan Pharmaceuticals, Inc.” The
results of the combined operations have been included in the Company’s financial
statements since February 2003.
As
described above, the Company resulted from the February 21, 2003 reverse merger
between Atlantic Technology Ventures, Inc. (“Atlantic”), which was incorporated
on May 18, 1993, and privately-held Manhattan Research Development, Inc.,
incorporated on August 6, 2001. The Company was incorporated in the State of
Delaware. In connection with the merger, the former stockholders of Manhattan
Research received a number of shares of Atlantic's common stock so that
following the merger they collectively owned 80 percent of the outstanding
shares. Upon completion of the merger, Atlantic changed its name to Manhattan
Pharmaceuticals, Inc. and thereafter adopted the business of Manhattan
Research.
The
Company is a clinical stage biopharmaceutical company focused on developing
and
commercializing innovative pharmaceutical therapies for underserved patient
populations. The Company acquires rights to these technologies by licensing
or
otherwise acquiring an ownership interest, funding their research and
development and eventually either bringing the technologies to market or
out-licensing. We currently have four product candidates in development:
Hedrin™, a novel, non-insecticide treatment of pediculitis (head lice); Topical
PTH (1-34) for the treatment of psoriasis; Altoderm™ (topical cromolyn sodium)
for the treatment of pruritus associated with dermatologic conditions including
atopic dermatitis; and Altolyn™ (oral tablet cromolyn sodium) for the treatment
of mastocytosis. During 2007, the Company discontinued development of
Oleoyl-estrone and Propofol Lingual Spray.
Acquisition
of Tarpan Therapeutics, Inc.
On
April
1, 2005, the Company entered into an Agreement and Plan of Merger (the
“Agreement”) with Tarpan Therapeutics, Inc., a Delaware corporation (“Tarpan”),
and Tarpan Acquisition Corp., a Delaware corporation and wholly-owned subsidiary
of the Company (“TAC”). Under the Agreement TAC merged with and into Tarpan,
with Tarpan remaining as the surviving corporation and a wholly-owned subsidiary
of the Company (the “Merger”). The Merger was completed April 1, 2005. In
consideration for their shares of Tarpan capital stock and in accordance with
the Agreement, the stockholders of Tarpan received 10,731,052 shares of the
Company’s common stock such that, upon the effective time of the Merger, the
Tarpan stockholders collectively receivedapproximately 20 percent of the
Company’s then outstanding common stock on a fully-diluted basis. Based on the
five day average price of the Company’s common stock of $1.03 per share, the
value of the shares issued totaled $11,052,984. In addition, there were $166,184
of acquisition costs. At the time of the Merger, Tarpan had outstanding
indebtedness of $651,000 (inclusive of 5% accrued interest) resulting from
a
series of promissory notes issued to Paramount BioCapital Investments, LLC
and
Horizon BioMedical Ventures, LLC, both of which are owned or controlled by
Dr.
Lindsay Rosenwald. The notes were repaid in full by the Company in two
installments on April 15, 2005 and September 6, 2005.
F-8
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
The
acquisition of Tarpan has been accounted for by the Company under the purchase
method of accounting in accordance with Statement of Financial Accounting
Standards (“SFAS”) No. 141 “Business Combinations”. Under the purchase method,
assets acquired and liabilities assumed by the Company are recorded at their
estimated fair values and the results of operations of the acquired company
are
consolidated with those of the Company from the date of
acquisition.
Several
of Tarpan’s former stockholders were directors or significant stockholders of
the Company at the time of the transaction. Dr. Rosenwald and various trusts
established for the benefit of Dr. Rosenwald and members of his immediate family
collectively beneficially owned approximately 46 percent of Tarpan’s common
stock and beneficially owned approximately 26 percent of the Company’s common
stock at the time of the transaction. In addition, Joshua Kazam, David Tanen,
Dr. Michael Weiser and Timothy McInerney, all of whom were members of the
Company’s board of directors at the time of the transaction, collectively owned
approximately 13.4 percent of Tarpan’s outstanding common stock. At the time of
the transaction, Dr. Weiser and Mr. McInerney were employed by Paramount
BioCapital, Inc., an entity owned and controlled by Dr. Rosenwald. As a result
of such relationships between the Company and Tarpan, the Company’s board of
directors established a special committee to consider and approve the Agreement.
The members of the special committee did not have any prior relationship with
Tarpan.
The
excess purchase price paid by the Company to acquire the net assets of Tarpan
was allocated to acquired in-process research and development totaling
$11,887,807. As required by Financial Accounting Standards Board (“FASB”)
Interpretation No. 4, “Applicability of FASB Statement No. 2 to Business
combinations Accounted for by the Purchase Method” (“FIN 4”), the Company
recorded a charge in its consolidated statement of operations for the year
ended
December 31, 2005 for the in-process research and development. Tarpan was a
biopharmaceutical company engaged in the development of the Phase II
pharmaceutical product candidate, PTH (1-34).
(2)
Liquidity
and Basis of Presentation
Liquidity
The
Company incurred a net loss of $12,032,252 and negative cash flows from
operating activities of $10,229,711 for the year ended December 31, 2007 and
a
net loss of $9,695,123 and negative cash flows from operating activities of
$7,750,738 for the year ended December 31, 2006. The net loss applicable to
common shares from date of inception, August 6, 2001, to December 31, 2007
amounts to $54,999,070.
The
Company received approximately $7.9 million net from a private placement of
common stock and warrants in March 2007. This private placement is more fully
described in Note 5.
F-9
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
The
Company received approximately $2.0 million from a joint venture agreement
in
February 2008. This joint venture agreement is more fully described in Note
12.
Management
believes that the Company will continue to incur net losses through at least
December 31, 2008 and for the foreseeable future thereafter. Based on the
resources of the Company available at December 31, 2007 and the net proceeds
received from the February 2008 joint venture agreement management does not
believe that the Company has sufficient capital to fund its operations through
2008. Management believes that the Company will need additional equity or debt
financing or will need to generate revenues through licensing of its products
or
entering into strategic alliances to be able to sustain its operations through
2008. Furthermore, we will need additional financing thereafter to complete
development and commercialization of our products. There can be no assurances
that we can successfully complete development and commercialization of our
products.
These
matters raise substantial doubt about the Company’s ability to continue as a
going concern. The accompanying consolidated financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
The
Company’s continued operations will depend on its ability to raise additional
funds through various potential sources such as equity and debt financing,
collaborative agreements, strategic alliances and its ability to realize the
full potential of its technology in development. Additional funds may not become
available on acceptable terms, and there can be no assurance that any additional
funding that the Company does obtain will be sufficient to meet the Company’s
needs in the long-term.
(3)
Summary of Significant Accounting Policies
Basis
of Presentation
The
Company has not generated any revenue from its operations and, accordingly,
the
consolidated financial statements have been prepared in accordance with the
provisions of SFAS No.7, “Accounting and Reporting by Development Stage
Enterprises.”
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All intercompany balances and transactions have
been
eliminated in consolidation. All of the Company’s subsidiaries were dissolved as
of December 31, 2006.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect certain reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and the reported amounts of expenses during the
reporting period. Actual results could differ from those
estimates.
F-10
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Research
and Development
All
research and development costs are expensed as incurred and include costs of
consultants who conduct research and development on behalf of the Company and
its subsidiaries. Costs related to the acquisition of technology rights and
patents for which development work is still in process are expensed as incurred
and considered a component of research and development costs.
The
Company often contracts with third parties to facilitate, coordinate and perform
agreed upon research and development of a new drug. To ensure that research
and
development costs are expensed as incurred, the Company records monthly accruals
for clinical trials and preclinical testing costs based on the work performed
under the contracts.
These
contracts typically call for the payment of fees for services at the initiation
of the contract and/or upon the achievement of certain milestones. This method
of payment often does not match the related expense recognition resulting in
either a prepayment, when the amounts paid are greater than the related research
and development costs expensed, or an accrued liability, when the amounts paid
are less than the related research and development costs expensed.
Acquired
in-process research and development
Costs
to
acquire in-process research and development projects and technologies which
have
no alternative future use at the date of acquisition are expensed.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax
assets and liabilities are recognized for the future tax consequences
attributable to temporary differences between financial statement carrying
amounts of existing assets and liabilities, and their respective tax bases
and
operating loss and tax credit carryforwards. Deferred tax assets and liabilities
are measured using enacted tax rates expected to apply to taxable income in
the
years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a change in tax
rates is recognized in income in the period that includes the enactment date.
A
valuation allowance is provided when it is more likely than not that some
portion or all of the deferred tax assets will not be realized.
Computation
of Net Loss per Common Share
Basic
net
loss per common share is calculated by dividing net loss applicable to common
shares by the weighted-average number of common shares outstanding for the
period. Diluted net loss per common share is the same as basic net loss per
common share, since potentially dilutive securities from stock options, stock
warrants and convertible preferred stock would have an antidilutive effect
because the Company incurred a net loss during each period presented. The
amounts of potentially dilutive securities excluded from the calculation were
16,903,292 and 13,383,229 shares at December 31, 2007 and 2006,
respectively.
F-11
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Share-Based
Compensation
The
Company has stockholder-approved stock incentive plans for employees, directors,
officers and consultants. Prior to January 1, 2006, the Company accounted for
the employee, director and officer plans using the intrinsic value method under
the recognition and measurement provisions of Accounting Principles Board
(“APB”) Opinion No.25, “Accounting for Stock Issued to Employees” and related
interpretations, as permitted by Statement of Financial Accounting Standards
(“SFAS” or “Statement”) No. 123, “Accounting for Stock-Based Compensation.”
Effective
January 1, 2006, the Company adopted SFAS No. 123(R), “Share-Based Payment,”
(“Statement 123(R)”) for employee options using the modified prospective
transition method. Statement 123(R) revised Statement 123 to eliminate the
option to use the intrinsic value method and required the Company to expense
the
fair value of all employee options over the vesting period. Under the modified
prospective transition method, the Company recognized compensation cost for
the
years ended December 31, 2007 and 2006 which includes a) period compensation
cost related to share-based payments granted prior to, but not yet vested,
as of
January 1, 2006, based on the grant date fair value estimated in accordance
with
the original provisions of Statement 123; and b) period compensation cost
related to share-based payments granted on or after January 1, 2006, based
on
the grant date fair value estimated in accordance with Statement 123(R). In
accordance with the modified prospective method, the Company has not restated
prior period results.
The
Company recognizes compensation expense related to stock option grants on a
straight-line basis over the vesting period. For the years ended December 31,
2007 and 2006, the Company recognized share-based employee compensation cost
of
$1,447,560 and $1,670,661, respectively, in accordance with Statement 123(R).
$890,124 of the $1,447,560 of expense recognized in 2007 resulted from the
grant
of stock options to officers, directors, and employees of the Company on or
prior to December 31, 2005. $1,500,690 of the $1,670,661 of the expense
recognized in 2006 resulted from the grants of stock options to officers,
directors and employees of the Company on or prior to December 31, 2005. The
balances for the years ended December 31, 2007 and 2006 of $557,436 and
$169,971, respectively, relate to the granting of stock options to employees
and
officers on or after January 1, 2006. The Company did not capitalize any
share-based compensation cost.
Options
granted to consultants and other non-employees are accounted for in accordance
with EITF No. 96-18 "Accounting for Equity Instruments That Are Issued to Other
than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services". Accordingly, such options are recorded at fair value at the date
of
grant and subsequently adjusted to fair valueat the end of each reporting
perioduntil such options vest, and the fair value of the options, as adjusted,
is amortized to consulting expenseover the related vesting period. As a result
of adjusting consultant and other non-employee options to fair value as of
December 31, 2007 and 2006 respectively, net of amortization, the Company
recognized an increase to general and administrative and research and
development expenses of $6,604 for the year ended December 31, 2007 and a
reduction to general and administrative and research and development expenses
of
$4,838 for the year ended December 31, 2006.
F-12
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
The
Company has allocated share-based compensation costs to general and
administrative and research and development expenses as follows:
2007
|
2006
|
||||||
General
and administrative expense:
|
|||||||
Share-based
employee compensation cost
|
$
|
891,897
|
$
|
1,176,618
|
|||
Share-based
consultant and non-employee cost
|
10,550
|
(29,842
|
)
|
||||
$
|
902,447
|
$
|
1,146,776
|
||||
Research
and development expense
|
|||||||
Share-based
employee compensation cost
|
$
|
555,663
|
$
|
494,043
|
|||
Share-based
consultant and non-employee cost
|
(17,154
|
)
|
34,680
|
||||
$
|
538,509
|
$
|
528,723
|
||||
Total
share-based cost
|
$
|
1,440,956
|
$
|
1,675,499
|
As
a
result of adopting Statement 123(R), net loss for the year ended December 31,
2006 was greater than if the Company had continued to account for share-based
compensation under APB 25 by approximately $1,671,000. The effect of adopting
Statement 123(R) on basic and diluted earnings per share for the year ended
December 31, 2006 was $0.03 per share.
To
compute compensation expense in 2007 and 2006 the Company estimated the fair
value of each option award on the date of grant using the Black-Scholes model.
The Company based the expected volatility assumption on a volatility index
of
peer companies as the Company did not have a sufficient number of years of
historical volatility of its common stock for the application of Statement
123
(R). The expected term of options granted represents the period of time that
options are expected to be outstanding. The Company estimated the expected
term
of stock options by the simplified method as prescribed in Staff Accounting
Bulletin No. 107. The expected forfeiture rates are based on the historical
employee forfeiture experiences. To
determine the risk-free interest rate, the Company utilized the U.S. Treasury
yield curve in effect at the time of grant with a term consistent with the
expected term of the Company’s awards. The Company has not declared a dividend
on its common stock since its inception and has no intentions of declaring
a
dividend in the foreseeable future and therefore used a dividend yield of zero.
The
following table shows the weighted average assumptions the Company used to
develop the fair value estimates for the determination of the compensation
charges in 2007 and 2006:
2007
|
2006
|
||||||
Expected
volatility
|
93%
|
|
84%
- 98%
|
|
|||
Dividend
yield
|
—
|
—
|
|||||
Expected
term (in years)
|
5
- 10
|
5
- 10
|
|||||
Risk-free
interest rate
|
3.6%
- 4.9%
|
|
4.45%
- 5.1%
|
|
|||
|
|||||||
Forfeiture
rate
|
7%
|
|
4%
|
|
F-13
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Financial
Instruments
At
December 31, 2007 and 2006, the fair values of cash and cash equivalents and
accounts payable approximate their carrying values due to the short-term nature
of these instruments.
Cash
and Cash Equivalents
Cash
equivalents consist of cash or short term investments with original maturities
at the time of purchase of three months or less.
Property
and Equipment
Property
and equipment are stated at cost. Depreciation is provided using the
straight-line method over estimated useful lives. When assets are retired or
otherwise disposed of, the cost and related accumulated depreciation are removed
from the accounts, and any resulting gain or loss is recognized in operations
for the period. Amortization of leasehold improvements is calculated using
the
straight-line method over the remaining term of the lease or the life of the
asset, whichever is shorter. The cost of repairs and maintenance is charged
to
operations as incurred; significant renewals and improvements are
capitalized.
Short-term
Investments
Short-term
investments are carried at market value since they are marketable and considered
available-for-sale. The Company did not have any short-term investments at
December 31, 2007 or 2006.
New
Accounting Pronouncements
In
September 2006, the FASB issued SFAS No. 157, “Fair
Value Measurements” (“SFAS 157”), which defines fair value, establishes a
framework for measuring fair value in accordance with generally accepted
accounting principles (“GAAP”) in the United States of America, and expands
disclosures about fair value measurements. SFAS 157 does not require any
new
fair value measurements under GAAP and is effective for fiscal years beginning
after November 15, 2007. The Company will adopt SFAS 157 as of January 1,
2008.
The effects of adoption will be determined by the types of instruments carried
at fair value in our financial statements at the time of adoption, as well
as
the method utilized to determine their fair values prior to adoption. Based
on
the Company’s current use of fair value measurements, SFAS 157 is not expected
to have a material effect on its results of operations or financial
position.
In
February 2007, the FASB issued SFAS No. 159, “The
Fair
Value Option for Financial Assets and Financial Liabilities,” (SFAS 159), which
provides companies with an option to report selected financial assets and
liabilities at fair value. SFAS 159 establishes presentation and disclosure
requirements designed to facilitate comparisons between companies that choose
different measurement attributes for similar types of assets and liabilities
and
highlights the effect of a company’s choice to use fair value on its earnings.
It also requires a company to display the fair value of those assets and
liabilities for which it has chosen to use fair value on the face of the
balance
sheet. SFAS 159 will be effective beginning January 1, 2008 and is not expected
to have a material impact on the Company’s consolidated financial
statements.
F-14
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
In
June
2007, the FASB issued EITF No. 07-3, “Accounting
for Nonrefundable Advance Payments for Goods or Services Received for use
in
Future Research and Development Activities” (“EITF No. 07-3”). EITF No. 07-3
states that nonrefundable advance payments for goods or services that will
be
used or rendered for future research and development activities should be
deferred and capitalized. Such amounts should be recognized as an expense
as the
related goods are delivered or the related services are performed. Entities
should continue to evaluate whether they expect the goods to be delivered
or
services to be rendered. If an entity does not expect the goods to be delivered
or services to be rendered, the capitalized advance payment should be charged
to
expense. The provisions of EITF No. 07-3 will be effective for the Company
on a
prospective basis beginning January 1, 2008, evaluated on a contract by contract
basis and is not expected to have a material impact on the Company’s
consolidated financial statements.
In
December 2007, the FASB issued SFAS No. 141(R), a revised version of SFAS
No.
141, “Business
Combinations.” The revision is intended to simplify existing guidance and
converge rulemaking under U.S. generally accepted accounting principles with
international accounting standards. This statement applies prospectively
to
business combinations where the acquisition date is on or after the beginning
of
the first annual reporting period beginning on or after December 15, 2008.
An
entity may not apply it before that date. The Company is currently evaluating
the impact of the provisions of the revision on its consolidated results
of
operations and financial condition.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements” (“SFAS 160”), which will require
noncontrolling interests (previously referred to as minority interests) to
be
treated as a separate component of equity, not as a liability or other item
outside of permanent equity. This statement applies to the accounting for
noncontrolling interests and transactions with noncontrolling interest holders
in consolidated financial statements. SFAS 160 will be applied prospectively
to
all noncontrolling interests, including any that arose before the effective
date
except that comparative period information must be recast to classify
noncontrolling interests in equity, attribute net income and other comprehensive
income to noncontrolling interests, and provide other disclosures required
by
SFAS 160. SFAS 160 is effective for periods beginning on or after December
15,
2008. We are currently evaluating the impact that SFAS 160 will have on our
consolidated financial statements.
The
FASB
and the Securities and Exchange Commission had issued certain other accounting
pronouncements as of December 31, 2007 that will become effective in subsequent
periods; however, the Company does not believe that any of those pronouncements
would have significantly affected its financial accounting measures or
disclosures had they been in effect during the years ended December 31, 2007
and
2006 and for the period from August 6, 2001 (inception) to December 31, 2007
or
that will have a significant effect at the time they become
effective.
(4)
Property and Equipment
Property
and equipment consists of the following at December 31:
2007
|
2006
|
||||||
Property
and equipment
|
$
|
226,010
|
$
|
244,040
|
|||
Less
accumulated depreciation
|
(181,477
|
)
|
(160,297
|
)
|
|||
Net
property and equipment
|
$
|
44,533
|
$
|
83,743
|
F-15
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
(5)
Stockholders’ Equity
As
described in Note 1 the Company completed a reverse acquisition of privately
held Manhattan Research Development, Inc. on February 21, 2003. In July 2003,
the Board of Directors adopted a resolution authorizing an amendment to the
certificate of incorporation providing for a 1-for-5 combination of the
Company’s common stock. The resolution approving the 1-for-5 combination was
thereafter consented to in writing by holders of a majority of the Company’s
outstanding common stock and became effective in September 2003. Accordingly,
all share and per share information in these consolidated financial statements
has been restated to retroactively reflect the 1-for-5 combination and the
effects of the Reverse Merger.
2001
During
2001, the Company issued 10,167,741 shares of its common stock to investors
for
subscriptions receivable of $4,000 or $0.0004 per share. During 2002, the
Company received the $4,000 subscription receivable.
2002
During
2002, the Company issued 2,541,935 shares of its common stock to Oleoyl-estrone
Developments, S.L. (“OED”) in conjunction with a license agreement (the OED
License Agreement”), as more fully described in Note 8. We valued these shares
at their then estimated fair value of $1,000.
During
2002, the Company issued options to purchase 1,292,294 shares of its common
stock in conjunction with several consulting agreements. The fair value of
these
options was $60,589. The Company expensed $22,721 in 2002 and $37,868 in
2003.
During
2002 and 2003 the Company completed two private placements. During 2002, the
Company issued 3,043,332 shares of its common stock at $0.63 per share and
warrants to purchase 304,333 of its common stock in a private placement. After
deducting commissions and other expenses relating to the private placement,
the
Company received net proceeds of $1,704,318.
2003
During
2003, the Company issued an additional 1,321,806 shares of its common stock
at
$0.63 per share and warrants to purchase 132,181 shares of its common stock.
After deducting commissions and other expenses relating to the private
placement, the Company received net proceeds of $743,691. In connection with
these private placements, the Company issued to the placement agent warrants
to
purchase 1,658,753 shares of its common stock.
As
described in Note 1, during 2003, the Company completed a reverse acquisition.
The Company issued 6,287,582 shares of its common stock with a value of
$2,336,241 in the reverse acquisition.
In
November 2003, the Company issued 1,000,000 shares of its newly-designated
Series A Convertible Preferred Stock (the “Convertible Preferred”) at a price of
$10 per share in a private placement. After deducting commissions and other
expenses relating to the private placement, the Company received net proceeds
of
$9,046,176. Each share of Convertible Preferred was convertible at the holder’s
election into shares of the Company’s common stock at a conversion price of
$1.10 per share. The conversion price of the Convertible Preferred was less
than
the market value of the Company’s common stock on the date of issuance.
Accordingly for the year ended December 31, 2003 the Company recorded a separate
charge to deficit accumulated during development stage for the beneficial
conversion feature associated with the issuance of Convertible Preferred of
$418,182. The Convertible Preferred had a payment-in-kind annual dividend of
five percent. Maxim
Group, LLC of New York, together with Paramount Capital, Inc., a related party,
acted as the placement agents in connection with the private
placement.
F-16
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
2004
During
2004, the Company issued 3,368,952 shares of its common stock at a price of
$1.10 per share in a private placement. After deducting commissions and other
expenses relating to the private placement, the Company received net proceeds
of
$3,361,718. In connection with the common stock private placement and the
Convertible Preferred private placement, the Company issued to the placement
agents a warrant to purchase 1,235,589 shares of its common stock.
During
2004 the Company recorded a dividend on the Convertible Preferred of $585,799.
24,901 shares of Convertible Preferred were issued in payment of $282,388 of
this in-kind dividend. Also during 2004, 170,528 shares of Convertible Preferred
were converted into 1,550,239 shares of the Company’s common stock at $1.10 per
share.
During
2004 the Company issued 27,600 shares of common stock upon the exercise of
stock
options.
During
2004, the Company issued warrant to purchase 110,000 shares of its common stock
in conjunction with three consulting agreements. The fair value of these
warrants was $120,968. The Company expensed $100,800 in 2004 and $20,168 in
2005.
2005
In
August
2005, the Company issued 11,917,680 shares of its common stock and warrants
to
purchase 2,383,508 shares of its common stock in a private placement at $1.11
and $1.15 per share. After deducting commissions and other expenses relating
to
the private placement the Company received net proceeds of $12,250,209.
Paramount BioCapital, Inc. (“Paramount”), an affiliate of a significant
stockholder of the Company, acted as placement agent and was paid cash
commissions and expenses of $967,968 of which $121,625 was paid to certain
selected dealers engaged by Paramount in the private placement. The Company
also
issued warrants to purchase 595,449 shares of common stock to Paramount and
certain select dealers, of which Paramount received warrants to purchase 517,184
common shares. Timothy McInerney and Dr. Michael Weiser, each a director of
the
Company, were employees of Paramount BioCapital, Inc. at the time of the
transaction.
During
2005 the Company recorded a dividend on the Convertible Preferred of $175,663.
41,781 shares of Convertible Preferred were issued in payment of this $175,663
in-kind dividend and the unpaid portion of the 2004 in-kind dividend, $303,411.
Also during 2005, the remaining 896,154 shares of Convertible preferred were
converted into 8,146,858 shares of the Company’s common stock.
During
2005, the Company issued 675,675 shares of its common stock at $1.11 per share
and warrants to purchase 135,135 shares of its common stock to Cato BioVentures,
an affiliate of Cato Research, Inc., in exchange for satisfaction of $750,000
of
accounts payable owed by the Company to Cato Research, Inc. Since the value
of
the shares and warrants issued was approximately $750,000, there is no impact
on
the statement of operations for this transaction.
F-17
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
During
2005 the Company issued 312,245 shares of common stock upon the exercise of
stock options and warrants.
As
described in Note 1, in April 2005, the Company completed the Merger with
Tarpan. In accordance with the Agreement, the stockholders of Tarpan received
10,731,052 shares of the Company’s common stock with a value of
$11,052,984.
2006
During
2006 the Company issued 27,341 shares of common stock upon the exercise of
warrants.
2007
On
March
30, 2007, the Company entered into a series of subscription agreements with
various institutional and other accredited investors for the issuance and sale
in a private placement of an aggregate of 10,185,502 shares of its common stock
for total net proceeds of approximately $7.85 million, after deducting
commissions and other costs of the transaction. Of the total amount of shares
issued, 10,129,947 were sold at a per share price of $0.84, and an additional
55,555 shares were sold to an entity affiliated with a director of the Company,
at a per share price of $0.90, the closing sale price of the common stock on
March 29, 2007. Pursuant to the subscription agreements, the Company also issued
to the investors 5-year warrants to purchase an aggregate of 3,564,897 shares
of
common stock at an exercise price of $1.00 per share. The warrants are
exercisable during the period commencing September 30, 2007 and ending March
30,
2012. Gross and net proceeds from the private placement were $8,559,155 and
$7,852,185, respectively.
Pursuant
to these subscription agreements the Company filed a registration statement
on
Form S-3 covering the resale of the shares issued in the private placement,
including the shares issuable upon exercise of the investor warrants and the
placement agent warrants, with the Securities and Exchange Commission on May
9,
2007, which was declared effective by the Securities and Exchange Commission
on
May 18, 2007.
The
Company engaged Paramount, an affiliate of a significant stockholder of the
Company, as its placement agent in connection with the private placement. In
consideration for its services, the Company paid aggregate cash commissions
of
approximately $600,000 and issued to Paramount a 5-year warrant to purchase
an
aggregate of 509,275 shares at an exercise price of $1.00 per
share.
(6)
Stock Options
2003
Stock Option Plan
In
December 2003, the Company established the 2003 Stock Option Plan (the “2003
Plan”), which provided for the granting of up to 5,400,000 options to officers,
directors, employees and consultants for the purchase of stock. In August 2005,
the Company increased the number of shares of common stock reserved for issuance
under the 2003 Plan by 2,000,000 shares. At December 31, 2006, 7,400,000 shares
were authorized for issuance. In May 2007, the Company increased the number
of
shares of common stock reserves for issuance under the 2003 Plan by 3,000,000
shares. At December 31, 2007, 10,400,000 shares were authorized for issuance.
The options have a maximum term of 10 years and vest over a period determined
by
the Company’s Board of Directors (generally 3 years) and are issued at an
exercise price equal to or greater than the fair market value of the shares
at
the date of grant. The 2003 Plan expires on December 10, 2013 or when all
options have been granted, whichever is sooner. Under the 2003 Plan, the Company
granted employees options to purchase an aggregate of 870,000 shares of common
stock at an exercise price of $0.95, 75,000 shares of common stock at an
exercise price of $0.82 and 397,500 shares of common stock at an exercise price
of $0.72 during the year ended December 31, 2007. In addition, 27,776 shares
of
common stock were issued during 2007 under the 2003 Plan.
F-18
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
At
December 31, 2007 there were 3,475,626 shares reserved for future grants under
the 2003 Plan.
1995
Stock Option Plan
In
July
1995, the Company established the 1995 Stock Option Plan (the “1995 Plan”),
which provided for the granting of options to purchase up to 130,000 shares
of
the Company’s common stock to officers, directors, employees and consultants.
The 1995 Plan was amended several times to increase the number shares reserved
for stock option grants. In June 2005 the 1995 Plan expired and no further
options can be granted. At December 31, 2007 options to purchase 1,137,240
shares were outstanding and no shares were reserved for future stock option
grants under the 1995 Plan.
A
summary
of the status of the Company’s stock options as of December 31, 2007 and changes
during the year then ended is presented below:
2007
|
|||||||||||||
Shares
|
Weighted
average
exercise
price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at beginning of year
|
7,000,504
|
$
|
1.310
|
||||||||||
Granted
|
1,342,500
|
$
|
0.875
|
||||||||||
Exercised
|
-
|
||||||||||||
Cancelled
|
(309,166
|
)
|
$
|
0.336
|
|||||||||
8,033,838
|
$
|
1.253
|
6.887
|
$
|
|
||||||||
Options
exercisable at year-end
|
5,601,714
|
$
|
1.263
|
6.625
|
$
|
|
|||||||
Weighted-average
fair value of options granted during the year
|
$ |
0.63
|
As
of
December 31, 2007 and 2006, the total compensation cost related to non-vested
option awards not yet recognized is $539,046 and $1,365,581, respectively.
The
weighted average period over which it is expected to be recognized is
approximately 0.5 and 0.9 years, respectively.
F-19
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
The
following table summarizes the information about stock options outstanding
at
December 31, 2007:
Number
|
Remaining
|
Number
of
|
|||||||||
Exercise
|
of
Options
|
Contractual
|
Options
|
||||||||
Price
|
Outstanding
|
Life
(years)
|
Exercisable
|
||||||||
|
|
|
|
||||||||
$ |
0.40
|
876,090
|
5.16
|
876,090
|
|||||||
0.43
|
400
|
5.15
|
400
|
||||||||
0.70
|
220,000
|
8.53
|
73,333
|
||||||||
0.72
|
365,000
|
9.09
|
32,500
|
||||||||
0.82
|
75,000
|
9.08
|
-
|
||||||||
0.89
|
16,667
|
8.38
|
16,667
|
||||||||
0.95
|
670,000
|
9.32
|
100,000
|
||||||||
0.97
|
440,000
|
6.75
|
440,000
|
||||||||
1.00
|
65,000
|
4.24
|
65,000
|
||||||||
1.00
|
290,698
|
7.04
|
290,698
|
||||||||
1.25
|
12,000
|
4.08
|
12,000
|
||||||||
1.25
|
163,750
|
4.14
|
163,750
|
||||||||
1.35
|
108,333
|
8.08
|
64,999
|
||||||||
1.35
|
300,000
|
8.09
|
300,000
|
||||||||
1.35
|
60,000
|
8.53
|
20,000
|
||||||||
1.50
|
2,923,900
|
7.25
|
1,949,277
|
||||||||
1.50
|
250,000
|
2.58
|
25,000
|
||||||||
1.60
|
100,000
|
7.46
|
75,000
|
||||||||
1.65
|
1,077,000
|
6.08
|
1,077,000
|
||||||||
4.38
|
10,000
|
3.14
|
10,000
|
||||||||
20.94
|
10,000
|
2.28
|
10,000
|
||||||||
Total
|
8,033,838
|
5,601,714
|
(7)
Stock Warrants
The
following table summarizes the information about warrants to purchase shares
of
our common stock outstanding at December 31, 2007:
Number
of
|
Remaining
|
Number
of
|
|||||||||
Exercise
price
|
Warrants
outstanding
|
contractual
life
(years)
|
warrants
exercisable
|
||||||||
$
|
0.28
|
150,000
|
4.64
|
150,000
|
|||||||
0.78
|
10,000
|
1.98
|
10,000
|
||||||||
1.00
|
3,564,897
|
4.25
|
3,564,897
|
||||||||
1.00
|
509,275
|
4.25
|
509,275
|
||||||||
1.10
|
909,090
|
.85
|
909,090
|
||||||||
1.10
|
326,499
|
1.04
|
326,499
|
||||||||
1.44
|
2,161,767
|
2.65
|
2,161,767
|
||||||||
1.44
|
540,449
|
2.65
|
540,449
|
||||||||
1.44
|
135,135
|
2.65
|
135,135
|
||||||||
1.49
|
221,741
|
2.67
|
221,741
|
||||||||
1.49
|
55,000
|
2.67
|
55,000
|
||||||||
1.90
|
10,000
|
1.21
|
10,000
|
||||||||
1.90
|
90,000
|
1.21
|
90,000
|
||||||||
6.69
|
185,601
|
.10
|
185,601
|
||||||||
Total
|
8,869,454
|
8,869,454
|
F-20
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
(8)
Related-Party Transactions
Oleoylestrone
Developments, SL
The
Company entered into a consulting agreement with OED. The agreement became
effective in February 2002, at a fee of $6,250 per month. The agreement was
terminated in November 2007. The fees associated with the consulting agreement
are expensed as incurred. OED currently owns approximately 5.7 percent of the
Company’s outstanding common stock. Additionally, Mr. Pons, chief executive
officer of OED, was a member of the Company’s board of directors until his
resignation in July 2007.
Total
milestone payments under the license agreement of $0, $250,000 and $675,000
and
consulting fees of $68,750, $75,000 and $431,250 are included in the
accompanying consolidated statements of operations for the years ended December
31, 2007, 2006 and for the cumulative period from August 6, 2001 to December
31,
2007.
Paramount
BioCapital, Inc.
One
member of the Company’s board of directors, Timothy McInerney, was an employee
of Paramount or one of its affiliates until April 2007. Another member of the
Company’s board of directors, Michael Weiser, was an employee of Paramount until
December 2006. In addition, two former members of the Company’s board of
directors, Joshua Kazam and David Tanen, were employed by Paramount through
August 2004 and were directors of the Company until September 2005. The sole
shareholder of Paramount is Lindsay A. Rosenwald, M.D. Dr. Rosenwald
beneficially owns more than 5 percent of the Company’s common stock as of
December 31, 2007 and various trusts established for Dr. Rosenwald’s or his
family’s benefit, held in excess of 12% of the Company’s common stock as of
December 31, 2007. In November 2003, the Company paid to Paramount approximately
$460,000 as commissions earned in consideration for placement agent services
rendered in connection with the private placement of the Company’s Series A
Convertible Preferred Stock, which amount represented 7 percent of the value
of
the shares sold by Paramount in the offering. In addition, in January 2004,
the
Company paid approximately $260,000 as commissions earned in consideration
for
placement agent services rendered by Paramount in connection with a private
placement of the Company’s common stock, which amount represented 7 percent of
the value of the shares sold by Paramount in the private placement. In
connection with both private placements and as a result of their employment
with
Paramount, Mr. Kazam, Mr. McInerney and Dr. Weiser were allocated 5-year
placement agent warrants to purchase 60,174, 58,642 and 103,655 shares of the
Company’s common stock, respectively, at a price of $1.10 per
share.
Paramount
also served as the Company’s placement agent in connection with the August 2005
private placement. As placement agent, the Company paid to Paramount total
cash
commissions of $839,816 relating to the August 26, 2005 closing, of which
$121,625 was paid to certain selected dealers engaged by Paramount in connection
with the private placement and issued five-year warrants to purchase an
aggregate of 540,449 shares of common stock exercisable at a price of $1.44
per
share, of which Paramount received warrants to purchase 462,184 common shares.
In connection with the August 30 closing, the Company paid cash commissions
to
Paramount of $88,550 and issued an additional five-year warrant to purchase
55,000 common shares exercisable at a price of $1.49 per share.
F-21
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Paramount
also served as the Company’s placement agent in connection with the March 2007
private placement. As placement agent, the Company paid to Paramount aggregate
cash commissions of approximately $600,000 and issued to Paramount a 5-year
warrant to purchase an aggregate of 509,275 shares of common stock at an
exercise price of $1.00 per share.
(9)
Income Taxes
There
was
no current or deferred tax expense for the years ended December31, 2007 or
2006
because of the Company’s operating losses.
The
components of deferred tax assets as of December31, 2007 and 2006 are as
follows:
2007
|
2006
|
||||||
Deferred
tax assets:
|
|||||||
Tax
loss carryforwards
|
$
|
22,513,000
|
$
|
18,265,000
|
|||
Research
and development credit
|
1,769,000
|
1,374,000
|
|||||
In-process
research and development charge
|
4,850,000
|
4,850,000
|
|||||
Stock
based compensation
|
1,270,000
|
682,000
|
|||||
Other
|
85,000
|
29,000
|
|||||
Gross
deferred tax assets
|
30,487,000
|
25,200,000
|
|||||
Less
valuation allowance
|
(30,487,000
|
)
|
(25,200,000
|
)
|
|||
Net
deferred tax assets
|
$
|
—
|
$
|
—
|
The
reasons for the difference between actual income tax benefit for the years
ended
December31, 2007 and 2006 and the amount computed by applying the statutory
federal income tax rate to losses before income tax benefit are as
follows:
2007
|
2006
|
||||||||||||
%
of
|
%
of
|
||||||||||||
pretax
|
pretax
|
||||||||||||
Amount
|
loss
|
Amount
|
loss
|
||||||||||
Federal
income tax benefit at statutory rate
|
$
|
(4,102,000
|
)
|
(34.0
|
)%
|
$
|
(3,296,000
|
)
|
(34.0
|
)%
|
|||
State
income taxes, net of federal tax
|
(820,000
|
)
|
(6.8
|
)%
|
(659,000
|
)
|
(6.8
|
)%
|
|||||
Research
and development credits
|
(366,000
|
)
|
(3.0
|
)%
|
(200,000
|
)
|
(1.7
|
)%
|
|||||
Other
|
1,000
|
0.0
|
%
|
(166,000
|
)
|
(2.1
|
)%
|
||||||
Change
in valuation
|
|||||||||||||
allowance
|
5,287,000
|
43.8
|
%
|
4,321,000
|
44.6
|
%
|
|||||||
|
— |
—
|
%
|
—
|
—
|
%
|
F-22
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
A
valuation allowance is provided when it is more likely than not that some
portion or all of the deferred tax assets will not be realized. The net change
in the total valuation allowance for the years ended December 31, 2007 and
2006
was an increase of $5,287,000 and $4,321,000, respectively. The tax benefit
assumed using the federal statutory tax rate of 34% has been reduced to an
actual benefit of zero due principally to the aforementioned valuation
allowance.
At
December 31, 2007, the Company had unused federal and state net operating
loss
carryforwards of approximately $56,963,000 and $46,261,000, respectively.
The
net operating loss carryforwards expire in various amounts through 2027 for
federal and state income tax purposes. The Tax Reform Act of 1986 contains
provisions which limit the ability to utilize net operating loss carryforwards
in the case of certain events including significant changes in ownership
interests. Accordingly, a substantial portion of the Company’s net operating
loss carryforwards above will be subject to annual limitations (currently
approximately $100,000) in reducing any future year’s taxable income. At
December 31, 2007, the Company also had research and development credit
carryforwards of approximately $1,769,000 for federal income tax purposes
which
expire in various amounts through 2027.
The
Company files income tax returns in the U.S. Federal, State and Local
jurisdictions. With certain exceptions, the Company is no longer subject
to U.S.
federal and state income tax examinations by tax authorities for years prior
to
2004. The Company adopted the provisions of FIN 48, “Accounting for Uncertainty
in Income Taxes - an interpretation of FASB Statement No. 109” on January 1,
2007 with no material impact to the consolidated financial statements. The
Company had no unrecognized tax benefits during 2007 that would affect the
annual effective tax rate and no unrecognized tax benefits as of January
1, 2007
and December 31, 2007. Further, the Company is unaware of any positions for
which it is reasonably possible that the total amounts of unrecognized tax
benefits will significantly increase or decrease within the next twelve
months.
(10)
License and Consulting Agreements
IGI
Agreement for PTH (1-34)
On
April
1, 2005, as part of the acquisition of Tarpan Therapeutics, Inc., the Company
acquired a Sublicense Agreement with IGI, Inc. (the “IGI Agreement”) dated April
14, 2004. Under the IGI Agreement the Company received the exclusive,
world-wide, royalty bearing sublicense to develop and commercialize the licensed
technology (see Note 1). Under the terms of the IGI Agreement, the Company
is
responsible for the cost of the preclinical and clinical development of the
project, including research and development, manufacturing, laboratory and
clinical testing and trials and marketing of licensed products for which the
company will be responsible.
In
consideration for the Company’s rights under the IGI Agreement, a payment of
$300,000 was made upon execution of the agreement, prior to the Company’s
acquisition of Tarpan. In addition the IGI Agreement requires the Company to
make certain milestone payments as follows: $300,000 payable upon the
commencement of a Phase 2 clinical trial; $500,000 upon the commencement of
a
Phase 3 clinical trial; $1,500,000 upon the acceptance of an NDA application
by
the FDA; $2,400,000 upon the approval of an NDA by the FDA; $500,000 upon the
commencement of a Phase 3 clinical trial for an indication other than psoriasis;
$1,500,000 upon the acceptance of and NDA application for an indication other
than psoriasis by the FDA; and $2,400,000 upon the approval of an NDA for an
indication other than psoriasis by the FDA.
F-23
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
During
2007, we achieved the milestone of the commencement of Phase 2 clinical trial.
As a result $300,000 became payable to IGI. This $300,000 is included in
research and development expense for the year ended December 31, 2007. Payment
was made to IGI in February 2008. At December 31, 2007 this $300,000 liability
is reflected in accounts payable.
In
addition, the Company is obligated to pay IGI, Inc. an annual royalty of 6%
annual net sales on annual net sales up to $200,000,000. In any calendar year
in
which net sales exceed $200,000,000, the Company is obligated to pay IGI, Inc.
an annual royalty of 9% annual net sales. Through December 31, 2007, the Company
has not paid any such royalties.
IGI,
Inc.
may terminate the agreement (i) upon 60 days’ notice if the Company fails to
make any required milestone or royalty payments, or (ii) if the Company becomes
bankrupt or if a petition in bankruptcy is filed, or if the Company is placed
in
the hands of a receiver or trustee for the benefit of creditors. IGI, Inc.
may
terminate the agreement upon 60 days’ written notice and an opportunity to cure
in the event the Company commits a material breach or default. Eighteen months
from the date of the IGI Agreement, the Company may terminate the agreement
in
whole or as to any portion of the PTH patent rights upon 90 days’ notice to IGI,
Inc.
Hedrin
License Agreement
On
June
26, 2007, the Company entered into an exclusive license agreement for “Hedrin”
(the “Hedrin License Agreement”) with Thornton & Ross Ltd. (“T&R”) and
Kerris, S.A. (“Kerris”). Pursuant to the Hedrin License Agreement, the Company
has acquired an exclusive North American license to certain patent rights and
other intellectual property relating to Hedrin(TM), a non-insecticide product
candidate for the treatment of head lice. In addition, on June 26, 2007, the
Company entered into a supply agreement with T&R pursuant to which T&R
will be the Company’s exclusive supplier of Hedrin product the “Hedrin Supply
Agreement”.
In
consideration for the license, the Company issued to T&R and Kerris
(jointly, the “Licensor”) a combined total of 150,000 shares of its common stock
valued at $120,000. In addition, the Company also made a cash payment of
$600,000 to the Licensor. These amounts are included in research and development
expense. Further, the Company agreed to make future milestone payments to the
Licensor in the aggregate amount of $2,500,000 upon the achievement of various
clinical, regulatory, and patent issuance milestones, as well as up to
$2,500,000 in a one-time success fee based on aggregate sales of the product
by
the Company and its licensees of at least $50,000,000. The Company also agreed
to pay royalties of 8% (or, under certain circumstances, 4%) on net sales of
licensed products. The Company’s exclusivity under the Hedrin License Agreement
is subject to an annual minimum royalty payment of $1,000,000 (or, under certain
circumstances, $500,000) in each of the third through seventh years following
the first commercial sale of Hedrin. The Company may sublicense its rights
under
the Hedrin Agreement with the consent of Licensor and the proceeds resulting
from such sublicenses will be shared with the Licensor.
Pursuant
to the supply agreement, the Company has agreed that it and its sublicensees
will purchase their respective requirements of the Hedrin product from T&R
at agreed upon prices. Under certain circumstances where T&R is unable to
supply Hedrin products in accordance with the terms and conditions of the Supply
Agreement, the Company may obtain products from an alternative supplier subject
to certain conditions. The term of the Supply Agreement ends upon termination
of
the Hedrin Agreement.
F-24
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
In
February 2008 the Company assigned and transferred its rights in Hedrin to
joint
venture, see note 12- Subsequent Events, Joint Venture with Nordic.
Altoderm
License Agreement
On
April
3, 2007, the Company entered into a license agreement for “Altoderm” (the
“Altoderm Agreement”) with T&R. Pursuant to the Altoderm Agreement, the
Company acquired an exclusive North American license to certain patent rights
and other intellectual property relating to Altoderm, a topical skin lotion
product candidate using sodium cromoglicate for the treatment of atopic
dermatitis. In accordance with the terms of the Altoderm Agreement, the Company
issued 125,000 shares of its common stock, valued at $112,500, and made a cash
payment of $475,000 to T&R upon the execution of the agreement. These
amounts have been included in research and development expense. Further, the
Company agreed to make future milestone payments to T&R comprised of various
combinations of cash and common stock in respective aggregate amounts of
$5,675,000 and 875,000 shares of common stock upon the achievement of various
clinical and regulatory milestones. The Company also agreed to pay royalties
on
net sales of products using the licensed patent rights at rates ranging from
10%
to 20%, depending on the level of annual net sales, and subject to an annual
minimum royalty payment of $1 million in each year following the first
commercial sale of Altoderm. The Company may sublicense the patent rights.
The
Company agreed to pay T&R 30% of the royalties received by the Company under
such sublicense agreements.
Altolyn
License Agreement
On
April
3, 2007, the Company and T&R also entered into a license agreement for
“Altolyn” (the “Altolyn Agreement”). Pursuant to the Altolyn Agreement, the
Company acquired an exclusive North American license to certain patent rights
and other intellectual property relating to Altolyn, an oral formulation product
candidate using sodium cromoglicate for the treatment of mastocytosis, food
allergies, and inflammatory bowel disorder. In accordance with the terms of
the
Altolyn Agreement, the Company made a cash payment of $475,000 to T&R upon
the execution of the agreement. This amount is included in research and
development expense. Further, the Company agreed to make future cash milestone
payments to T&R in an aggregate amount of $5,675,000 upon the achievement of
various clinical and regulatory milestones. The Company also agreed to pay
royalties on net sales of products using the licensed patent rights at rates
ranging from 10% to 20%, depending on the level of annual net sales, and subject
to an annual minimum royalty payment of $1 million in each year following the
first commercial sale of Altolyn. The Company may sublicense the patent rights.
The Company agreed to pay T&R 30% of the royalties received by the Company
under such sublicense agreements.
OED
License Agreement for Oleoyl-estrone
On
February 15, 2002, the Company entered into a License Agreement (the "License
Agreement") with OED. Under the terms of the License Agreement, OED granted
to
the Company a world-wide license to make, use, lease and sell the products
incorporating the licensed technology (see Note 1). OED also granted to the
Company the right to sublicense to third parties the licensed technology or
aspects of the licensed technology with the prior written consent of OED. OED
retains an irrevocable, nonexclusive, royalty-free right to use the licensed
technology solely for its internal, noncommercial use. The License Agreement
shall terminate automatically upon the date of the last to expire patent
contained in the licensed technology or upon the Company's bankruptcy. OED
may
terminate the License Agreement in the event of a material breach by the Company
that is not cured within the notice period. The Company may terminate the
License Agreement for any reason upon 60 days notice. The Company terminated
this agreement in November 2007.
F-25
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
In
addition to the License Agreement, the Company entered into a consulting
agreement with OED. The agreement became effective in February 2002, at a fee
of
$6,250 per month, and terminated when the License Agreement terminated. The
fees
associated with the consulting agreement are expensed as incurred.
Under
the
License Agreement, the Company agreed to pay to OED certain licensing fees
which
are being expensed as they are incurred. The Company paid $175,000 in up front
licensing fees which is included in 2002 research and development expense.
In
addition, pursuant to the License Agreement, the Company issued 1,000,000 shares
of its common stock to OED. The Company valued these shares at their then
estimated fair value of $1,000.
In
connection with the License Agreement, the Company has agreed to milestone
payments to OED as follows:
(i)
$250,000 upon the treatment of the first patient in a Phase I clinical trial
under a Company-sponsored investigational new drug application ("IND"), which
was paid in 2005; (ii) $250,000 upon the treatment of the first patient in
a
Phase II clinical trial under a Company-sponsored IND, which was paid in 2006;
(iii) $750,000 upon the first successful completion of a Company-sponsored
Phase
II clinical trial under a Company-sponsored IND; (iv) $2,000,000 upon the first
successful completion of a Company-sponsored Phase III clinical trial under
a
Company sponsored IND; and (v) $6,000,000 upon the first final approval of
the
first new drug application for the first licensed product by the United States
Food and Drug Administration (“FDA”). Through December 31, 2007, the Company
paid a total of $675,000 in licensing fees and milestone payments. The Company
has no further financial liability or commitment to OED under the License
Agreement.
NovaDel
Agreement for Propofol Lingual Spray
In
April
2003, the Company entered into a license and development agreement with NovaDel,
under which the Company received certain worldwide, exclusive rights to develop
and commercialize products related to NovaDel’s proprietary lingual spray
technology for delivering propofol for pre-procedural sedation. Under the terms
of this agreement, the Company agreed to use its commercially reasonable efforts
to develop and commercialize the licensed products, to obtain necessary
regulatory approvals and to thereafter exploit the licensed products. The
agreement also provides that NovaDel will undertake to perform, at the Company’s
expense, a substantial portion of the development activities, including, without
limitation, preparation and filing of various applications with applicable
regulatory authorities.
In
consideration for the Company’s rights under the NovaDel license agreement, the
Company paid NovaDel an initial license fee of $500,000 in 2003. In addition,
the license agreement requires the Company to make certain milestone payments
as
follows: $1,000,000 payable following the date that the first NDA for lingual
spray propofol is accepted for review by the FDA; $1,000,000 following the
date
that the first European Marketing Application is accepted for review by any
European Union country; $2,000,000 following the date when the first filed
NDA
for lingual spray propofol is approved by the FDA; $2,000,000 following the
date
when the first filed European Marketing Application for lingual spray propofol
is accepted for review; $1,000,000 following the date on which an application
for commercial approval of lingual spray propofol is approved by the appropriate
regulatory authority in each of Australia, Canada, Japan and South Africa;
and
$50,000 following the date on which an application for commercial approval
for
lingual spray propofol is approved in any other country (other than the U.S.,
a
member of the European Union, Australia, Canada, Japan or South Africa).
F-26
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
In
addition, the Company is obligated to pay to NovaDel an annual royalty based
on
a fixed rate of net sales of licensed products, or if greater, the annual
royalty is based on the Company’s net profits from the sale of licensed products
at a rate that is twice the net sales rate. In the event the Company sublicenses
the licensed product to a third party, the Company is obligated to pay royalties
based on a fixed rate of fees or royalties received from the sublicensee until
such time as the Company recovers its out-of-pocket costs, and thereafter the
royalty rate doubles. Because of the continuing development efforts required
of
NovaDel under the agreement, the royalty rates are substantially higher than
customary for the industry. Through December 31, 2007, the Company has incurred,
and paid a total of $500,000 under the NovaDel license agreement, the initial
license fee paid in 2003. The Company terminated this agreement during 2007
and
has no continuing obligations under this agreement.
(11)
Commitments and Contingencies
Swiss
Pharma
Swiss
Pharma Contract LTD (“Swiss Pharma”), a clinical site that the Company used in
one of its obesity trials, gave notice to the Company that Swiss Pharma believes
it is entitled to receive an additional payment of $322,776 for services in
connection with that clinical trial. While the contract between the Company
and
Swiss Pharma provides for additional payments if certain conditions are met,
Swiss Parma has not specified which conditions they believe have been achieved
and the Company does not believe that Swiss Pharma is entitled to additional
payments and has not accrued any of these costs as of December 31, 2007. The
contract between the Company and Swiss Pharma provides for arbitration in the
event of a dispute, such as this claim for an additional payment. Swiss Pharma
has filed a demand for arbitration. As the Company does not believe that Swiss
Pharma is entitled to additional payments, it intends to defend its position
in
arbitration. The arbitration is currently in its initial stages.
Therapeutics,
Inc.
During
2007, we entered into an agreement with Therapeutics, Inc. for the conduct
of a
Phase 2a clinical trial of PTH (1-34). The amount of the agreement is
approximately $845,000. At December 31, 2007, we recognized research and
development expense of $483,000 related to the conduct of this clinical trial.
At December 31, 2007, we recognized prepaid expense of $19,000 related to this
clinical trial. The remaining financial commitment related to the conduct of
the
clinical trial is approximately $340,000. This clinical trial is expected to
conclude in the second quarter of 2008.
Contentions
of a Former Employee
In
February 2007, a former employee of the Company alleged an ownership interest
in
two of the Company’s provisional patent applications. Also, without articulating
precise legal claims, the former employee contends that the Company wrongfully
characterized the former employee’s separation from employment as a resignation
instead of a dismissal in an effort to harm the former employee’s immigration
sponsorship efforts, and, further, to wrongfully deprive the former employee
of
the former employee’s alleged rights in two of the Company’s provisional patent
applications. The former employee is seeking an unspecified amount in damages.
The Company refutes the former employee’s contentions and intends to vigorously
defend itself should the former employee file claims against the Company. There
have been no further developments with respect to these
contentions.
F-27
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Employment
Agreement
The
Company has employment agreements with two employees for the payment of
aggregate annual base salary of $530,000 as well as performance based bonuses.
These agreements have three year terms and have a remaining obligation of
$394,000 as of December 31, 2007.
Leases
The
Company leases office space under a non-cancellable lease terminating in
September 2008. Rent expense was $141,012 for each of the years ended December
31, 2007 and 2006.
Future
minimum rental payments subsequent to December 31, 2007 under an operating
lease
for the Company’s office facility are as follows:
Years
Ending December 31,
|
Commitment
|
|||
2008
|
$
|
100,000
|
||
2009
and subsequent
|
$
|
0
|
12.
Subsequent events
Joint
Venture with Nordic
In
February 2008, the Company and Nordic Biotech Advisors ApS through its
investment fund Nordic Biotech Venture Fund II K/S (“Nordic”) entered into a
50/50 joint venture agreement (the “Hedrin JV”) to develop and commercialize the
Company's North American rights (under license) to its Hedrin product.
Pursuant
to the Hedrin JV Agreement, Nordic formed a new Danish limited partnership
(the
"Hedrin JV") and provided it with initial funding of $2.5 million. The Company
assigned and transfered its North American rights in Hedrin to the Hedrin JV
in
return for a $2.0 million cash payment and equity in the Hedrin JV representing
50% of the nominal equity interests in the Hedrin JV .
Should
the Hedrin JV be successful in achieving a payment milestone, namely that by
September 30, 2008, the FDA determines to treat Hedrin as a medical device,
Nordic will purchase an additional $2.5 million of equity in the Hedrin JV,
whereupon the Hedrin JV will pay the Company an additional $1.5 million in
cash
and issue to the Company an additional $2.5 million in equity in the Hedrin
JV,
thereby maintaining the Company’s 50% ownership interest in the Hedrin
JV.
The
Hedrin JV will be responsible for the development and commercialization of
Hedrin for the North American market and all associated costs including clinical
trials, if required, regulatory costs, patent costs, and future milestone
payments owed to T&R, the licensor of Hedrin.
The
Hedrin JV will engage the Company to provide management services to the Limited
Partnership in exchange for an annualized management fee, which for 2008, on
an
annualized basis, is $527,000.
F-28
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Nordic
paid to the Company a non-refundable fee of $150,000 at the closing for the
right to receive a warrant covering 7.1 million shares of the Company’s common
stock, exercisable for $0.14 per share. The warrant is issuable 90 days from
closing, provided Nordic has not exercised all or a part of its put, as
described below. The per share exercise price of the warrant was based on the
volume weighted average price of the Company’s common stock for the period prior
to the signing of the Hedrin JV Agreement.
Nordic
has an option to put all or a portion of its equity interest in the Hedrin
JV to
the Company in exchange for the Company’s common stock. The shares of the
Company’s common stock to be issued upon exercise of the put will be calculated
by multiplying the percentage of Nordic’s equity in the Hedrin JV p that Nordic
decides to put to the Company multiplied by the dollar amount of Nordic’s
investment in Limited Partnership divided by $0.14, as adjusted from time to
time. The put option is exercisable immediately and expires at the earlier
of
ten years or when Nordic’s distributions from the Limited Hedrin JV exceed five
times the amount Nordic invested in the Hedrin JV.
The
Company has an option to call all or a portion of Nordic’s equity interest in
the Hedrin JV in exchange for the Company’s common stock. The Company cannot
begin to exercise its call until the price of the Company’s common stock has
closed at or above $1.40 per share for 30 consecutive trading days. During
the
first 30 consecutive trading day period in which the Company’s common stock
closes at or above $1.40 per share the Company can exercise up to 25% of its
call option. During the second 30 consecutive trading day period in which the
Company’s common stock closes at or above $1.40 per share the Company can
exercise up to 50% of its call option on a cumulative basis. During the third
30
consecutive trading day period in which the Company’s common stock closes at or
above $1.40 per share the Company can exercise up to 75% of its call option
on a
cumulative basis. During the fourth 30 consecutive trading day period in which
the Company’s common stock closes at or above $1.40 per share the Company can
exercise up to 100% of its call option on a cumulative basis. The shares of
the
Company’s common stock to be issued upon exercise of the call will be calculated
by multiplying the percentage of Nordic’s equity in the Limited Partnership that
the Company calls, as described above, multiplied by the dollar amount of
Nordic’s investment in the Hedrin JV divided by $0.14. Nordic can refuse the
Company’s call by either paying the Company up to $1.5 million or forfeiting all
or a portion of their put, calculated on a pro rata basis for the percentage
of
the Nordic equity interest called by the Company.
The
Hedrin JV 's Board will consist of 4 members, 2 appointed by the Company and
2
appointed by Nordic. Nordic has the right to appoint one of the directors as
chairman of the Board. The chairman has certain tie breaking powers. In the
event that the payment milestone described above is not achieved by June 30,
2008, then the Hedrin JV 's Board will increase to 5 members, 2 appointed by
the
Company and 3 appointed by Nordic.
After
the
closing, at Nordic's request, the Company will nominate a person identified
by
Nordic to serve on the Company’s Board of Directors.
F-29
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
The
Company will grant Nordic registration rights for the shares to be issued upon
exercise of the warrant, the put or the call. The Company is required to file
an
initial registration statement within 10 calendar days of filing its Form 10-K
for the year ended December 31, 2007. The Company is required to file additional
registration statements, if required, within 45 days of the date the Company
first knows that such additional registration statement was required. The
Company is required to use commercially reasonable efforts to cause the
registration statement to be declared effective by the Securities and Exchange
Commission (“SEC”) within 105 calendar days from the filing date. If the Company
fails to file a registration statement on time or if a registration statement
is
not declared effective by the SEC within 105 days of filing the Company will
be
required to pay to Nordic, or its assigns, an amount in cash, as partial
liquidated damages, equal to 0.5% per month of the amount invested in the Hedrin
JV by Nordic until the registration statement is declared effective by the
SEC.
In no event shall the aggregate amount payable by the Company exceed 9% of
the
amount invested in the Hedrin JV by Nordic.
The
profits of the Hedrin JV will be shared by the Company and Nordic in accordance
with their respective equity interests in Limited Partnership, which are
currently 50% to each, except that Nordic will get a minimum guaranteed return
from the Hedrin JV equal to 5% on Hedrin sales, as adjusted for any change
in
Nordic’s equity interest in the Limited Partnership. If the Hedrin JV realizes a
profit equal to or greater than a 10% royalty on Hedrin sales, then profits
will
be shared by the Company and Nordic in accordance with their respective equity
interests in the Limited Partnership. However, in the event of a liquidation
of
the Limited Partnership, Nordic’s distribution in liquidation will be at least
equal to the amount Nordic invested in the Hedrin JV ($5 million if the payment
milestone described above is met, $2.5 million if it is not met) plus 10% per
year, less the cumulative distributions received by Nordic from the Hedrin
JV.
Further, in no event shall Nordic’s distribution in liquidation be greater than
assets available for distribution in liquidation.
American
Stock Exchange
In
September 2007, we received notice from the staff of AMEX, indicating that
we
were not in compliance with certain continued listing standards set forth in the
American Stock Exchange Company guide. Specifically, the American Stock Exchange
notice cited our failure to comply, as of June 30, 2007, with section
1003(a)(ii) of the AMEX Company Guide as we had less than $4,000,000 of
stockholders’ equity and had losses from continuing operations and /or net
losses in three or four of our most recent fiscal years and with section
1003(a)(iii) which requires us to maintain $6,000,000 of stockholders’ equity if
we have experienced losses from continuing operations and /or net losses in
its
five most recent fiscal years.
In
order
to maintain our AMEX listing, we were required to submit a plan to AMEX advising
the exchange of the actions we have taken, or will take, that would bring us
into compliance with all the continued listing standards by April 16, 2008.
We
submitted such a plan in October 2007. If we are not in compliance with the
continued listing standards at the end of the plan period, or if we do not
make
progress consistent with the plan during the period, AMEX staff may initiate
delisting proceedings.
Under
the
terms of the Joint Venture Agreement, the number of potentially issuable shares
represented by the put and call features of the Hedrin agreement, and the
warrant issuable to Nordic, would exceed 19.9% of our total outstanding shares
and would be issued at a price below the greater of book or market value. As
a
result, under AMEX regulations, we would not be able to complete the transaction
without first receiving either stockholder approval for the transaction, or
a
formal “financial viability” exception from AMEX’s stockholder approval
requirement. We estimate that obtaining stockholder approval to comply with
AMEX
regulations would take a minimum of 45 days to complete. We have discussed
the
financial viability exception with AMEX for several weeks and have neither
received the exception nor been denied the exception. We determined that our
financial condition required us to complete the transaction immediately, and
that the Company’s financial viability depends on its completion of the
transaction without further delay.
F-30
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Accordingly,
to maintain the Company’s financial viability, on February 28, 2008 we announced
that we had formally notified the AMEX that we intend to voluntarily delist
our
common stock from AMEX. The delisting became effective on March 26,
2008.
Our
common stock now trades on the Over the Counter Bulletin Board (“OCTBB”) under
the symbol “MHAN”. We intend to maintain corporate governance, disclosure and
reporting procedures consistent with applicable law.
F-31
Index
to Exhibits Filed with this Report
Exhibit
No.
|
Description
|
|
10.11
|
Separation
Agreement between the Registrant and Alan G. Harris dated December
21,
2007.
|
|
10.19
|
Joint
Venture Agreement between Nordic Biotech fund II K/S and Manhattan
Pharmaceuticals, Inc. to develop and commercialize “Hedrin” dated January
31, 2008.
|
|
10.20
|
Amendment
No. 1, dated February 25, 2008, to the Joint Venture Agreement between
Nordic Biotech fund II K/S and Manhattan Pharmaceuticals, Inc. to
develop
and commercialize “Hedrin” dated January 31, 2008.
|
|
10.21
|
Assignment
and Contribution Agreement between Hedrin Pharmaceuticals K/S and
Manhattan Pharmaceuticals, Inc. dated February 25,
2008.
|
|
10.22
|
Registration
Rights Agreement between Nordic Biotech Venture Fund II K/S and Manhattan
Pharmaceuticals, Inc. dated February 25, 2008.
|
|
10.23
|
Amendment
to Employment Agreement by and between Manhattan Pharmaceuticals,
Inc. and
Douglas Abel
|
|
23.1
|
Consent
of J.H. Cohn LLP.
|
|
31.1
|
Certification
of Principal Executive Officer.
|
|
31.2
|
Certification
of Principal Financial Officer.
|
|
32.1
|
Certifications
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|